News Article | April 20, 2017
DUBLIN, Apr. 20, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Pharmacovigilance" conference to their offering. This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in...
News Article | April 20, 2017
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan. This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance. Key Topics to Be Addressed at the Pharmacovigilance Conference: - Principles of Pharmacovigilance and Data Resources - Risk Management and Risk Minimisation - Causality Assessment: Clinical Diagnosis of Adverse Events - PASS and PAES Studies - Regulatory Framework - European Post-Marketing Pharmacovigilance Regulations - Pharmacoepidemiological Studies - Evolution of PSURs, PBRERs and DSURs - Pro-active Pharmacovigilance Pre- and Post Marketing - Clinical Trial ADR reporting requirements - Risk/Benefit Assessment - Drug Surveillance in countries outside Europe - Examples of pharmacoepidemiological studies used in risk management - Introduction to Signal detection - Introduction to Risk Management plans - Practical Pharmacovigilance Workshop Agenda: Day 1 Schedule 09.00 Registration and coffee 09.30 Principles of Pharmacovigilance and Data Resources - Basic principles of monitoring drug safety - An overview of methodology - Data resources available for monitoring and evaluating drug safety - Responding to drug safety signals Risk Management and Risk Minimisation: Basic Principles - Basic principles - Proactive strategies - Principles of risk minimisation - PASS and PAES studies Causality Assessment: Clinical Diagnosis of Adverse Events - The principles of causality assessment with practical examples - Medical evaluation of individual reports of adverse events - Strategies for follow up The Current Regulatory Framework and its Global Impact - Overview of European regulatory framework, including new EU pharmacovigilance legislation - Implications for global environment - the links to ICH and CIOMs recommendations - Inspections and penalties for non-compliance - Practical applications of definitions European Post-Marketing Pharmacovigilance Regulations Overview of requirements which will include: - The role of Pharmacovigilance Risk Assessment Committee and SCOPE initiative - Quality Management Systems and the - Pharmacovigilance System Master File (PSMF) - QPPV - Expedited Reporting solicited vs spontaneous - Periodic reports and Signal Management - Risk Management Plans and Risk Minimisation - Post Authorisation Safety and Efficacy studies (PASS/PAES) - Additional Monitoring - Pharmacovigilance Inspections/audit - Public Hearings - Stakeholder involvement initiatives such as PROTECT, WEB-RADR 17.15 End of Day One and Drinks Reception Day 2 Schedule 09.30 Pro-Active Pharmacovigilance Pre-and Post Marketing - Anticipating drug safety issues in development of small molecules and biologics - What specific and non-specific safety monitoring should be done? - Handling safety signals in development - Differences between pre-marketing studies and post-marketing experience Risk/Benefit Assessment - General principles - Quantifying risk - Taking action to optimise benefit/risk - Monitoring the effectiveness of risk management measures Clinical: Trial ADR Reporting Requirements - IH E2A and general requirements - Expedited reports - EU Clinical Trials Directive and detailed guidance - US IND requirements - Development Safety Update Reports (DSURs) Pharmacoepidemiology Studies - Basic Designs, Strenghts, Weaknesses and Examples - Real world data is the King - Randomisation in the real world - Drugs and devices - its all exposure - Tracking all patients? Where are We Now with PSURs (or PBRERs) - Evolution of the PSUR, PBRER and DSUR - ICH E2C, Volume 9A, GVP Module VII and ICH E2C (R2) What do we submit now and when is it required? - Practical aspects of compiling PSURs - The link between DSURs, RMPs, PSURs, and Core Safety Information 17.00 Close of day two Day 3 Schedule 09.30 Drug Surveillance in Countries Outside Europe - US culture - NDA and IND safety reporting - Inspections - Japan culture - Post-marketing safety surveillance programmes in Japan - Pharmacovigilance in other countries Practicalities of Signal Detection - Definitions of signals - Regulatory guidances on signal detection by industry and regulators - Resources for signal detection - Quantitative v qualitative signal detection Examples of Pharmacoepidemiological Studies Used in Risk Management - Prescription event monitoring - Prospective observational cohort studies - Case control studies - Drug registries (anti-TNFs) - Pregnancy registries Practicalities of Risk Management A real world example of the development of a successful EU risk management plan - Requirements of risk management plans from an industry point of view - How to write a successful risk management plan - Reporting results of outcomes of activities in the risk management plan - Updating a risk management plan Practical Pharmacovigilance Workshop As requested by previous participants in this course, this session will comprise a practical case study with valuable hands-on experience covering: - Handling an important safety alert from regulators - Assessment of risk - Determining measures to respond to previously unidentified risks - Continuing assessmnet and communication of risk benefit 16.00 Close of day three For more information about this conference visit http://www.researchandmarkets.com/research/2scctz/pharmacovigilance Research and Markets Laura Wood, Senior Manager email@example.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/three-day-pharmacovigilance-course-london-united-kingdom---december-4-5-6-2017---research-and-markets-300442736.html
News Article | May 5, 2017
JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that data suggests that women with relapsing forms of multiple sclerosis (RMS) who were exposed to COPAXONE® 20 mg/mL daily during pregnancy are not at higher risk for congenital anomalies compared to reference rates for abnormal pregnancy outcomes reported in two large databases representing the general population. These data appeared as an “Online First” article on the Website of the International Journal of MS Care (IJMSC) and represent the largest published analysis of pregnancy pharmacovigilance data for an RMS treatment. MS is more common among women of childbearing age compared with any other age group. The average age of diagnosis is 30, and many women go on to have children after diagnosis. Approximately half of pregnancies are unintended, which means that women with MS may become pregnant unexpectedly while taking an MS treatment. None of the MS therapies are approved for use during pregnancy. “Physicians now have this data to consider as they consult with their RMS patients planning a family or already pregnant, to make individual treatment decisions,” said Patricia K. Coyle, M.D., professor and vice chair (clinical affairs) of neurology, and the director of the Multiple Sclerosis Comprehensive Care Center at the Stony Brook University Medical Center, Stony Brook, New York. The analysis published in IJMSC compared 5,025 pregnancy cases with known outcomes from the Glatiramer Acetate (GA) Pharmacovigilance Database to two other databases of healthy women, the Metropolitan Atlanta Congenital Defects Program (MACDP)1 and the European Surveillance of Congenital Anomalies (EUROCAT)2. When compared to the rate of congenital anomalies from the MACDP database, the rate for prospective pregnancies among women exposed to COPAXONE® while pregnant from the GA Pharmacovigilance Database was comparable to the general U.S. population. Similarly, the comparison between the GA Pharmacovigilance and EUROCAT data indicated that the rate of congenital anomalies is very similar to that of the general European population. “With more than 20 years of data collected on COPAXONE®, we are able to share this important analysis with physicians to consider and counsel their patients of child-bearing age,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “We are pleased to put forward this data that may help facilitate that conversation.” The publication, “Pregnancy Outcomes from the Branded Glatiramer Acetate Pregnancy Database,” is available online at http://ijmsc.org/doi/abs/10.7224/1537-2073.2016-079. The International Journal of MS Care is the official peer-reviewed publication of the Consortium of Multiple Sclerosis Centers (CMSC). COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. COPAXONE® is rated as Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Administration of glatiramer acetate by subcutaneous injection to pregnant rats and rabbits resulted in no adverse effects on offspring development. Animal reproduction studies are not always predictive of human response, therefore COPAXONE® should be used during pregnancy only if clearly needed. See additional important information at: www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries. Patients allergic to glatiramer acetate or mannitol should not take COPAXONE®. Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, patients should call the emergency phone number in their area. Patients should call their doctor right away if they develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, patients should not give themselves any more injections until their doctor tells them to begin again. Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. Patients may experience more than one such episode, usually beginning at least one month after starting treatment. Patients should tell their doctor if they experience chest pain that lasts for a long time or feels very intense. A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Patients should follow proper injection technique and inform their doctor of any skin changes. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, patients should ask their doctor or pharmacist. Patients should tell their doctor about any side effects they have while taking COPAXONE®. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits of COPAXONE® which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Population-based tracking system for birth defects. The MACDP was established in 1967 by the Centers for Disease Control and Prevention (CDC), Emory University, and the Georgia Mental Health Institute. 2 European network of population-based registries for the epidemiologic surveillance of congenital anomalies
News Article | April 18, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Introduction to Veterinary Pharmacovigilance" conference to their offering. This course has been designed to provide basis training and a good introduction to those concerned with Veterinary Pharmacovigilance. New entrants, support staff we well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will be plenty of time for interaction, questions and answers to enable participants to get a good understanding of this complex subject. This course will be beneficial for those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role. Adverse event monitoring and drug safety officers together with regulatory affairs and personnel from registration departments will find this seminar useful. The Current Regulatory Framework and its Global Impact - Overview of European regulatory framework, including Volume IXb and implications of the proposed EU pharmacovigilance legislation - The principles of causality assessment with practical examples Minimising the Impact of Data with Errors - Format and content of the PSUR Discussion will take place throughout the two days For more information about this conference visit http://www.researchandmarkets.com/research/p3crqc/introduction_to
News Article | May 5, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "World Pharmacovigilance and Drug Safety Software Market by Functionality - Opportunities and Forecasts, 2014 - 2022" report to their offering. There are several drivers, restraints and opportunities shaping the future of the market. Important factors including growing incidences of ADRs have played a major role in driving the pharmacovigilance and drug safety software market. Furthermore, rising adoption rate of such software by many outsourcing companies too have kept the future of the market bright. On the other hand, government entities including FDA, EMEA and others, has increased the pressure on the biotechnology and pharmaceutical brands to manufacture safe drugs. The aforesaid factor has also added to the increasing market share of the industry. However, lack of awareness about the benefits associated with the pharmacovigilance and drug safety software market has hampered its market growth. Regions such as Asia Pacific and Latin America are likely to create greater opportunities for the market. The market is segmented based on functions, delivery model, end-customers and geography. Based on function the market segments discussed in the report consists of issue tracking solution, fully integrated solution, adverse event reporting solution etc. The mode of delivery assessed in the market research report includes on -demand and on premise delivery. The major end-customers examined during the study are pharma companies, CROs, BPOs and others. Geographies promising growth includes North America, Asia Pacific, Europe and LAMEA. A closer look at the competitive landscape reveals that major IT brands are busy launching pharmacovigilance and drug safety software and generating clients in the same month itself. Prominent market players are also seen acquiring new companies or local market players to maintain their competitive edge. Other business strategies favored by the companies include constant upgradation, joint ventures and collaborations. Prominent market players discussed in the market research report are Oracle Corporation, Online Business Applications, Inc., Sparta Systems, Inc., United BioSource Corporation and others. For more information about this report visit http://www.researchandmarkets.com/research/b3297v/world
News Article | February 17, 2017
TORONTO, ON--(Marketwired - February 17, 2017) - Axiom Real-Time Metrics, the premier provider of eClinical software solutions and services to small to mid-sized life sciences organizations, will be exhibiting at the Outsourcing in Clinical Trials event on the West Coast taking place in Burlingame, California on February 22-23, 2017. Axiom invites attendees to join them for gourmet coffee and a conversation at Booth 36. OCT West 2017 will bring together over 700 clinical professionals, including senior level executives from the pharmaceutical, biotech, and medical device sectors to discuss clinical outsourcing strategies and address key challenges within clinical operations. Axiom's Fusion eClinical suite and the unified modules Randomization, Inventory Management and Safety Management will be showcased at the conference. "Our team is excited to meet with attendees and share information about the benefits and value of our award winning product suite. Fusion delivers powerful, enterprise level software made for small to mid-size organizations. We provide a truly Unified eClinical suite and are always excited to share and illustrate what this distinction of being 'Truly Unified' really means and what sets us apart," says Andrew Schachter CEO and Founder. Christopher Kata, Axiom's CIO further offers, "Fusion, Axiom's product suite has been engineered with our design & programming teams, and directed through years of client input. All of our technology is delivered from a single source. We provide our 'peerless' Unified product and services to leading edge life science organizations around the world, and, true to our Mission we are partners in this journey together. This means that it eliminates having a separate EDC, randomization and adjudication vendor -- Fusion does it all!" Headquartered in Toronto, Canada, Axiom delivers intuitive, powerful and cost-effective eClinical solutions and services focused around your entire study. Services include: DM, Biostatistics and Pharmacovigilance. Axiom's eClinical suite, Fusion, delivers a powerful range of innovative end-user focused, unified functionality and 15 modules. Axiom serves as the Connected Hub for your entire clinical study data and operational needs. Fusion Delivers: EDC, DM, IWRS, CTMS, Inventory Management, IVR, Patient Portal, AE/SAE Tracking, Safety Database, Central Lab, Imaging, eTMF, and 24/7 Project and Clinical Data Reporting. For more information, please visit http://www.axiommetrics.com/.
News Article | March 1, 2017
Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, is pleased to announce the appointments of Françoise Bono, PhD, to the role of Chief Scientific Officer and Olivier de Beaumont, MD, MBA, to the role of Chief Medical Officer. Their very specialized expertise will enable the Company to carry out its various projects, notably development activities on AsiDNA™, a first-in-class molecule acting as a tumor cell DNA repair inhibitor, as well as ongoing work to demonstrate belinostat’s potential in association with other anti-cancer agents in various types of tumor. It also represents a key asset just months before the interim results of the Livatag® Phase III trial. “Françoise and Olivier bring Onxeo a rare combination of extensive experience in the development of new treatments and an in-depth understanding of a biotech business model," commented Judith Greciet, Chief Executive Officer of Onxeo. "As a biotech company, our challenge is to bring our programs to major value inflection points as rapidly as possible on the basis of pertinent and attractive data, and thus drive the Company’s value. This is particularly important for AsiDNA™, which has substantial potential and for which the preclinical and clinical data generated over the coming months will be pivotal within this context. Francoise and Olivier’s arrival to lead our thought process and head our teams represents an undeniable asset for the implementation of our strategy." Previously, Françoise Bono spent over 25 years with Sanofi and Evotec and was, until late 2016, Evotec Executive Vice-President, Oncology. A prominent cancer biologist, she has brought several innovative compounds from early clinical development through to IND filing and Phase I trials. Françoise Bono has led over 20 major projects, notably in the field of immune-oncology, and developed extensive experience in science, people management and project leadership and evaluation, as well as recognized expertise in translational and development strategy in oncology. Françoise Bono received her PhD in Cellular Biology from Toulouse University. “I am delighted to be able to contribute to the development of Onxeo, which has successfully put together a promising and diverse portfolio based on innovative approaches liable to be a paradigm shift in the treatment of cancer. This is, for example, the case for the DNA repair inhibition technology that is behind AsiDNA™ and is one of the most exciting and promising of these novel approaches,” declared Françoise Bono. Since 2005, Olivier de Beaumont was with Stallergenes Greer as Senior Vice President, Head of Global Clinical Development, Pharmacovigilance and Medical Affairs, and a member of the Executive Committee. Prior to that, he led various clinical development programs and strategic marketing activities at Quintiles and Aventis, addressing a wide range of therapeutic areas and leading teams, notably in oncology. Dr. de Beaumont is a medical doctor and also holds a MBA from ESCP Business School and a Masters degree in Public Health & Health Economics. “I am thrilled to be joining Onxeo at this critical and transformative stage, and am extremely impressed by their tremendous drive to become an innovation engine in oncology. I am proud to be joining this experienced and dedicated team to help develop pioneering solutions that will address the unmet needs of cancer patients,” said Olivier de Beaumont. Prior to these appointments, preclinical and clinical operations were a single department. Former CSO Graham Dixon left the Company to pursue other opportunities. Under this new structure, Françoise Bono and her team will now focus on preclinical activities in collaboration with Olivier de Beaumont’s teams, who will henceforth be responsible for clinical development. Both Dr. Bono and Dr. de Beaumont are members of the Executive Committee and will be active participants in the Company’s strategic planning, partnering discussions, and presentations to investors and other key stakeholders. Onxeo is a biotechnology company developing innovative drugs for the treatment of orphan diseases in oncology, driven by high therapeutic demand in one of the fastest growing segments of the pharmaceutical industry. Onxeo’s objective is to become a major international player in the field of rare cancers. Its growth strategy is founded on the development of innovative, effective, and safe drugs based on breakthrough technologies that can make a real difference in the treatment of orphan oncology diseases and considerably improve the quality of life of patients affected by rare or resistant cancers. Onxeo’s comprehensive portfolio features a broad orphan oncology pipeline, with 3 major products in several on-going preclinical and clinical programs, alone or in combination for various cancer indications. The Company is headquartered in Paris, France with offices in Denmark and in New York, and has approximately 60 employees. Onxeo is listed on Euronext in Paris, France and Nasdaq Copenhagen, Denmark (Ticker: ONXEO, ISIN Code: FR0010095596). This communication expressly or implicitly contains certain forward-looking statements concerning Onxeo and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Onxeo to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Onxeo is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of Onxeo to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the 2015 Reference Document filed with the AMF on April 29, 2016, which is available on the AMF website (http://www.amf-france.org) or on the company’s website (www.onxeo.com).
News Article | November 28, 2016
North America region held the largest share of the pharmacovigilance and drug safety software market in 2014. However, Asian and Latin American countries symbolize high growth markets. This is owing to a rise in research outsourcing by pharmaceutical giants and growing public and private investments in pharmaceutical R&D in these emerging nations. The global pharmacovigilance and drug safety software market is expected to grow at a CAGR of 6.5% from 2014 to 2019. Complete report on Pharmacovigilance and Drug Safety Software Market spread across 210 Pages, Profiling 10 Companies and Supported with 74 Tables and 87 Figures is now available at http://www.reportsnreports.com/reports/354423-pharmacovigilance-and-drug-safety-software-market-by-functionality-adverse-event-reporting-fully-integrated-software-delivery-mode-on-premise-on-demand-cloud-based-saas-end-user-pharma-biotech-companies-cros-bpos-global-forecast-to-2019.html . In this report, the global pharmacovigilance and drug safety software market has been classified into four segments on the basis of functionality, namely, adverse event reporting software, drug safety audits software, issue tracking software, and fully integrated software. The global pharmacovigilance and drug safety software market is segmented into two segments on the basis of delivery mode, namely, on-premise delivery mode and on-demand/cloud based (SaaS) delivery mode. The global pharmacovigilance and drug safety software market is also segmented on the basis of end users including pharma and biotech companies, contract research organizations (CROs), business process outsourcing (BPO) firms, and other pharmacovigilance service providers.Comprehensive information about lucrative emerging markets. The report analyzes the markets for various pharmacovigilance and drug safety software across geographies. Interested in this New Research Study the Sample Copy of this research is Available Now The global pharmacovigilance and drug safety software market comprises large number of small and mid-size software developers and service providers. As of 2014, the global pharmacovigilance and drug safety software market was dominated by Oracle Corporation (U.S.). New service launches; agreements, and partnerships;software developments; and geographical expansions are some of the major strategies adopted by most of the market players to achieve growth in the pharmacovigilance and drug safety software market. Some of the key players in the global pharmacovigilance software market include ArisGlobal (U.S.), Ennov Solutions Inc. (U.S.), EXTEDO GmbH (U.S.), Online Business Applications, Inc. (U.S.), Oracle Corporation (U.S.), Sarjen Systems Pvt. Ltd (India), Sparta Systems, Inc. (U.S.), and United BioSource Corporation (U.S.), among others. Click now for more Details, Queries and Discount this study “Pharmacovigilance and Drug Safety Software Market by Functionality (Adverse Event Reporting, Fully Integrated Software), Delivery Mode (On-premise, On-demand/Cloud based (SAAS)), End-user (Pharma & Biotech Companies, CROs, BPOs) - Global Forecast to 2019” report @ http://www.reportsnreports.com/contacts/discount.aspx?name=354423 . Thus, growing complexity related to drug safety regulations is expected to drive the growth of the market during the forecast period. New service launches; agreements, and partnerships; software developments; and geographical expansions are some of the key strategies adopted by most of the market players to achieve growth in the pharmacovigilance software market. Explore more reports on Healthcare at http://www.reportsnreports.com/market-research/healthcare/ .
News Article | February 22, 2017
RALEIGH, N.C., Feb. 22, 2017 (GLOBE NEWSWIRE) -- INC Research Holdings, Inc. (Nasdaq:INCR), a leading global Phase I to IV contract research organization, today announced expansion of its Functional Service Provider (FSP) service offering to include investigator payment processing, leveraging the Company’s extensive expertise and delivery of customized solutions in this area as well as insights gained from its industry-recognized site relationships. The addition of investigator payment processing to the Company’s FSP offering builds on its nearly 20 years of experience in meeting the needs of biopharmaceutical customers worldwide for standalone outsourced services under an FSP model, including Data Management, Medical Writing, Safety and Pharmacovigilance, and Site Contracts. “INC’s long history in working under the FSP business model, along with our proven track record in delivery of customized payment processing solutions for clinical research sites, are combining to create an exciting new offering for our customers,” said Tara Fitzgerald, President, Clinical Development Services and Head of the Company’s FSP offering. “We look forward to meeting the strong customer demand for services in this area while continuing to offer our customers a broad range of solutions that fit the way they want to work today — whether it be via a functional or full-service outsourcing model or both.” Delivery of INC’s Investigator Payment FSP services will be provided through a dedicated business unit led by Victoria Moore, Vice President, Investigator Payments, with hub locations in Raleigh, NC, US; Camberley, UK; and Gurgaon, India. The Company currently is providing Investigator Payment services for several large customers under both the FSP and full-service models. INC is leveraging the Medidata Payments Cloud, the only global site payment technology driven by an integrated Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS), as the foundation for its offering. Medidata Payments automates the clinical site payment workflow, processing high volumes of invoices and complex payment requests quickly and accurately. Streamlined, on-time, global investigator payments traditionally have been overlooked in the CRO industry as many specialized investigator payment providers lack the resources, technology and global payment execution. Leveraging the insights gained from its strong site relationships across the globe, INC was able to further improve its own processing of investigator payments and in turn offer improved and streamlined investigator payment processing solutions to customers. Functional service provision has become an increasing and important model to biopharmaceutical customers worldwide for outsourcing of clinical development services. Services typically outsourced under an FSP model include high-volume clinical development tasks that are repetitive and duplicated across many projects. INC Research offers customized FSP solutions to customers, including tactical outsourcing of certain functions on a specific trial as well as strategic outsourcing of an entire department or function such as investigator payment processing. The Company's FSP model uses strategic commitment and performance-based measures to improve productivity in key service areas. The end result is greater cost predictability and quality delivery of consistent services. About INC Research INC Research (Nasdaq:INCR) is a leading global contract research organization ("CRO") providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. The Company was ranked “Top CRO to Work With” among large global CROs in the 2015 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 110 countries. For more information, please visit www.incresearch.com and connect with us on LinkedIn and Twitter @inc_research.
News Article | February 15, 2017
APCER Life Sciences, Inc., the truly global provider of safety, medical, regulatory and technology services, and Advera Health Analytics, Inc., a leading healthcare informatics company, today announced a wide-ranging partnership. Under the terms of their agreement, APCER Life Sciences will become an exclusive authorized reseller of Advera’s powerful Evidex™ platform for signal detection, comparative analysis, and outcomes research, and will integrate Evidex into its services offerings for drug safety and medical affairs. “Advera Health has built the big data solution that pharmacovigilance professionals have been waiting for – an easy-to-use platform to analyze, visualize, and find meaning in the accelerating volume of safety cases that are diligently documented and reported every day during development and post-marketing,” said Suneet Walia, President and CEO of APCER Life Sciences. “We are proud to become an exclusive partner to Advera and equip our safety and outcomes scientists with the Evidex platform to enhance the value we bring to our clients in signal detection, comparative safety reviews, and market access research.” Advera’s Evidex™ is a scalable, simple-to-use, web-based data and analytics platform that provides comprehensive coverage on the safety profiles of both approved and clinical stage drugs. Evidex features peer-reviewed, proprietary analytics, focused on safety signal detection and management. Its analytics are built upon core data assets from curated clinical trial results, the FDA Adverse Event Reporting System (FAERS), and client-provided data. Additionally, direct downstream medical cost calculations and outcomes analyses allow the impact of a product’s safety profile to be effectively communicated to all stakeholders. APCER’s clients will have the opportunity to utilize Advera’s Evidex™ platform and advisory services to better identify, manage, and communicate safety risks. ”As a leader in its field, APCER Life Sciences has recognized that proactive signal management, comparative safety research, real-world evidence generation, and commercial planning support are the areas that represent the future for pharmacovigilance,” said Brian M. Overstreet, president and CEO of Advera Health Analytics. “We are very pleased to partner with APCER Life Sciences, whose deep expertise in this market will help to inform our future development and accelerate the roll out of our services to meet the growing demand within their client base.” The announcement of the partnership coincides with the opening of the DIA Pharmacovigilance and Risk Management Strategies conference in Washington, DC, an annual forum that brings together industry, academia, regulators, and patient representatives for thought-provoking sessions and candid discussion of common challenges. Representatives of APCER Life Sciences and Advera Health Analytics will be on hand through Wednesday to debut the partnership and discuss their solutions at Table 11 in the Exhibitor Ballroom. About APCER Life Sciences APCER Life Sciences is committed to improving health in partnership with its clients. It brings together safety, medical, regulatory, and technology resources to ensure that patients receive the safest, most effective therapies possible. To learn how APCER Life Sciences works together for better health, please follow the company on Twitter, LinkedIn, and Facebook; visit http://www.apcerls.com; and contact APCER at one of their global offices. About Advera Health Analytics Advera Health Analytics is a healthcare informatics company that improves patient outcomes and reduces systemic healthcare costs through the comprehensive analysis of drug evidence. Utilizing proprietary data-mining and analytics, Advera Health makes evidence accessible, actionable, and predictable. Advera Health provides solutions to enterprise markets including managed care organizations, health systems and hospitals, and the pharmaceutical industry. Please visit http://www.adverahealth.com as well as our newsroom, blog, Twitter, and LinkedIn pages for more information about the company.