Waltham, MA, United States
Waltham, MA, United States

PAREXEL International is a multinational contract research organization , based in Waltham, Massachusetts and founded in 1982 by Josef H. von Rickenbach and Anne Sayigh. It provides services for companies in the pharmaceutical, biotechnology and medical device industries, including consulting, clinical studies and market launch. The name PAREXEL comes from Paracelsus, a Swiss physician considered as the father of modern toxicology. PAREXEL employs more than 15,000 people worldwide in over 50 countries and has supported leading biotechnology companies and several large pharmaceutical companies to bring new drugs to the market.The company has been ranked to FlexJobs' list of 100 Top Companies for Remote Jobs in 2014.The company provides services during all phases of the development of a drug, from planning to commercialization. It includes strategy development, clinical trials management, data management, biostatistical analysis, regulatory affairs, drug development consulting, medical marketing, training, publishing and advanced eClinical technology solutions. Wikipedia.


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The global medical device outsourcing market is expected to reach USD 88.2 billion by 2025 Rising price competition and rising need for reduction of production cost are the most impact rendering driver of the medical device outsourcing market. Sharp cutbacks in the public spending in major EU regions and the U.S., is the major issue currently faced by medical devices manufacturers. Increasing profitability pressure and growing competition coupled with high degree of industry maturity is expected to impact growth. The medical device outsourcing market is dynamic and highly competitive. Over the next seven years, the industry is expected to witness significant growth owing to steep decline in duration for product commercialization by companies in order to gain the advantage of being the first mover. Product design and development services are anticipated to be one of the highly availed services by device manufacturers over the forecast period. By opting for this service, manufacturers are expected to benefit in speeding up the time to market and faster return on investment, thereby supporting growth for this segment. Further key findings from the study suggest: - Shivna Medical Instruments Co., Ltd. - Mitutoyo Corporation - Daiichi Jitsugyo Co., Ltd. - GE Healthcare - Integer Holdings Corporation - Active Implants Corporation LLC - Cirtec Medical - MDMI Technologies, Inc. - Micro Systems Engineering GmbH - Creganna-Tactx Medical - Avail Medical Products Inc. - Sterigenics International Inc. - Hamilton Medical - Inteprod LLC - Kinetics Climax Inc. - CFI Medical - Omnica Corporation - Infinity Plastics Group - Teleflex Medical OEM - ProMed Molded Products, Inc. - Accell Clinical Research LLC - Medpace Inc. - Charles River Laboratories International Inc. - Covance Inc. - PAREXEL International Corporation - WuXi AppTec - Icon Plc - CERES GmbH Evaluation and Research - Decision Driver Analytics - PRC Clinical - Chiltern International Ltd. - Precision Bioservices - RCRI - SynteractHCR - Technomics Research - Celestica HealthTech - CoorsTek Medical LLC - Memry Corporation - Plexus Corporation - Cadence Inc. - Millstone Medical Outsourcing - HCL Technologies Ltd. - Code Refinery LLC - Phase 2 Medical Device Manufacturing - Dravon Medical Inc. For more information about this report visit http://www.researchandmarkets.com/research/5n8p78/medical_device To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-medical-device-outsourcing-market-analysis-2014-2017-and-2025---research-and-markets-300446964.html


BOSTON--(BUSINESS WIRE)--PAREXEL International Corporation (NASDAQ: PRXL) will release financial results for the Third Quarter Fiscal Year 2017 on Wednesday, May 3, 2017 after the close of the stock market. PAREXEL will host a conference call and live webcast at 10:00 a.m. ET on Thursday, May 4, 2017 to discuss the results. To access the webcast, visit the Investor Section of PAREXEL’s website at www.PAREXEL.com. This webcast will continue to be accessible for one year following the live broadcast. To participate via telephone, dial (408) 940-3886 and ask to join PAREXEL’s Third Quarter Fiscal Year 2017 conference call. PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 18,625 employees in the second quarter. For more information about PAREXEL International visit www.PAREXEL.com.


News Article | May 4, 2017
Site: www.prnewswire.com

NEW YORK, May 4, 2017 /PRNewswire/ -- According to Stratistics MRC, the Global Electronic Data Capture (EDC) market is accounted for $XX million in 2016 and is expected to reach $XX million by 2022 growing at a CAGR of XX% from 2016 to 2022. Read the full report: http://www.reportlinker.com/p04823112/Electronic-Data-Capture-EDC-Systems-Global-Market-Outlook.html Factors such as improvements in the information management and analysis, increasing product pipeline, improved compilation of technical & scientific data, increasing outsourcing by pharmaceutical and biotechnological companies and demand from EDC services are contributing towards market growth. Growing adoption of cloud-based services by manufacturers and installation of fully integrated services will provide lucrative opportunity for the market growth. However, lack of skilled research professionals is restraining the market growth. Services segment is leading the market because of large number of Contract Research Organizations (CROs) presence. The web-based delivery mode is anticipated to be the largest market share owing to acceptance of inexpensive information management in clinical trials. In the development phase segment, Phase I is estimated to grow at a significant rate because of direct data and remote information capturing as well as rising R&D expenditure on the development of novel drugs . CROs is projected to be the largest market as the majority of them use commercially developed enterprise applications to support clinical development in phase II and phase III trials. North America is the leading market due to presence of major pharmaceutical companies. Asia Pacific is anticipated to be the fastest growing market because many pharmaceutical companies are using eClinical solutions. Some of the key players in global Electronic Data Capture (EDC) market are BioClinica,Clinical CLINIPACE, INC.,DATATRAK International, Inc., Medidata Solution, Inc, Merge Healthcare Incorporated, Omni Comm Systems, Inc., Openclinica, LLC, Oracle Corporation and PAREXEL International Corporation. Delivery Modes Covered: - Cloud-Based - Licensed Enterprise - Web Based Development Phases Covered: - Phase I - Phase II - Phase III - Phase IV Applications Covered: - Academic Institutes - Pharma & Biotech Organizations - CROs - Hospitals - Medical Device Manufacturers Components Covered: - Services - Software Regions Covered: - North America o US o Canada o Mexico - Europe o Germany o France o Italy o UK o Spain o Rest of Europe - Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific - Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements Read the full report: http://www.reportlinker.com/p04823112/Electronic-Data-Capture-EDC-Systems-Global-Market-Outlook.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/electronic-data-capture-edc-systems---global-market-outlook-2016-2022-300451981.html


News Article | February 27, 2017
Site: www.prnewswire.co.uk

The report "(CTMS) Clinical Trial Management System Market Size By Component (Software, Hardware, Services), By Product (Enterprise Based, Site Based), By Delivery Mode (Web, Cloud, On Premise), By End Use (Pharmaceutical & Biopharmaceutical Companies, Clinical Research Organizations, Healthcare Providers), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Poland, Russia, China, India, Japan, South Korea, Taiwan, Brazil, Mexico, South Africa), Growth Potential, Price Trends, Competitive Market Share & Forecast, 2016 - 2024" by Global Market Insights, Inc. says CTMS Market size is poised to surpass USD 2 billion by 2024. Growing prevalence of chronic diseases, surge in clinical trials outsourcing, rising R&D cost and favorable government initiatives will drive global clinical trial management system market size. Request for a sample of this research report @ https://www.gminsights.com/request-sample/detail/1155 Improvements in regulatory framework for drug approvals and patent laws along with rapid economic development in emerging countries of India and China will expand clinical trial management system market size.  Quality trials at reduced cost continues to remain unique proposition for regional industry growth. Stringent regulatory guidelines to ensure drug safety & efficacy, extended approval time, difficulties in recruitment for trials and increasing number of clinical trial failures in phase II and phase III should hinder clinical trial management system market growth. Hardware component was valued at over USD 90 million in 2015, and is estimated to expand at 13.1% CAGR from 2016 to 2024. Pharmaceutical companies are outsourcing their requirement to specialized firms in other regions. This has resulted in increase in sales of hardware components used for clinical trial management system. Enterprise based accounted for over 70% of clinical trial management system market share in 2015 and is projected to grow at 13.8% CAGR from 2016 to 2024. It provides dedicated services with special in house capabilities for clinical trials management. Cloud delivery mode is projected to witness robust growth of over 15% from 2016 to 2024 and expected to reach over USD 350 million by 2024. In terms of revenue share, Web and On Premise together account for over 85% clinical trial management market share in 2015, growing at over 14% and 11.5% from 2016 to 2024 respectively. Pharmaceutical and biopharmaceutical companies are estimated to surpass USD 1.4 billion by 2024. As these organizations are continuously striving to develop potent novel drugs and therapeutics to use against diseases and disorders. China clinical trial management system market size is anticipated to generate over USD 270 million in terms of value by 2024. Increasing government policies to setup a research center and growing R&D investments in life sciences, pharmaceutical, and clinical research industries, along with combination of HIS with CTMS, additionally the increased clinical research outsourcing and increasing prevalence of diseases. Browse key industry insights spread across 105 pages with 92 data tables & 6 figures & charts from this 2017 report Clinical Trial Management System Market in detail along with the table of contents at: U.S. clinical trial management system market share was over 70% of regional industry revenue in 2015. The factors driving business growth include favorable regulatory environment, effective ADR monitoring and evaluation policies and improved government funding. Germany clinical trial management system market size held more than 15% industry share in 2015 and anticipated to exceed USD 180 million by 2024. Favorable clinical trial regulations should boost the industry growth over the forecast period. India clinical trial management system market size was around USD 50 million in 2015, expected to witness robust growth of more than 22% from 2016 to 2024 due to growing preference for conducting clinical trials associated with its low cost and good quality of trials. Latin America clinical trial management system market size is expected to surpass USD 110 million by 2024, owing to favorable government regulations and increased adoption of new medical technologies in the areas of clinical chemistry and biomedical research. Global clinical trial management system industry is highly fragmented and competitive in nature. Some of the notable industry players include MedNet Solutions, Oracle Corporation, Bio-Optronics, BioClinica, Medidata solutions, PAREXEL International Corporation, Merge Healthcare, DATATRAK International, and VEEVA Systems. Other prominent participants include eClinForce, Forte Research Systems, and DSG. Make an inquiry for purchasing this report @ https://www.gminsights.com/inquiry-before-buying/1155 Clinical trial management system market research report includes in-depth coverage of the industry with estimates & forecast in terms of value and volume in USD million from 2012 to 2024 , for the following segments: The above information is provided on a regional and country basis for the following: Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider; offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.


News Article | February 2, 2017
Site: www.realwire.com

Acquisition will strengthen and add scale to current commercialisation and medical affairs services LONDON, February 2, 2017 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that the Company has entered into a definitive agreement to acquire The Medical Affairs Company, LLC (“TMAC”), a leading provider of outsourced medical affairs services to the pharmaceutical, biotechnology, and medical device industries. The acquisition is expected to close in February. Terms of the transaction were not disclosed. Founded in 2007, TMAC is a full-service contract medical organisation. TMAC offers strategic and tactical medical science liaison (MSLs) and clinical nurse educator support services in addition to medical affairs consulting, medical communications support, and direct placement services. TMAC is based in Kennesaw, Georgia, and has approximately 200 U.S.-based employees. Outsourcing medical affairs services presents a compelling option for biopharmaceutical companies as a way to reduce fixed costs. The increasingly complex nature of new products, and the need to demonstrate the therapeutic and reimbursement value of a product, is creating demand for credentialed healthcare professionals, such as MSLs, to lead clinically robust dialogues with key medical stakeholders on a peer-to-peer level. “The commercialisation-outsourcing market continues to grow as biopharmaceutical clients increasingly require medical affairs solutions to optimise awareness and understanding of their products in development or already on the market,” said Josef von Rickenbach, Chairman and CEO, PAREXEL. “As a company, we are focused on opportunities within commercialisation, market access, regulatory, pharmacovigilance, and medical outsourcing. With TMAC, PAREXEL will gain new and distinct medical affairs outsourcing capabilities that will strengthen and expand our commercialisation and market access offerings.” “We are excited to become a part of PAREXEL and offer our clients a comprehensive range of services delivered by a single company. Working together, PAREXEL and TMAC will deliver greater value to clients and meet evolving client needs, throughout the lifecycle of their products,” added Evan Demestihas, MD, RPh, Chief Executive Officer, TMAC. After the close of the acquisition, the TMAC management team will remain in place and continue to manage its employees and the services it currently provides to clients. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialisation continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 19,625 employees in the first quarter. For more information about PAREXEL International visit www.PAREXEL.com. PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners. This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ materially from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete the acquisition of The Medical Affairs Company, LLC and additional acquisitions, and to integrate newly acquired businesses including the acquisitions of The Medical Affairs Company, LLC, ExecuPharm, Inc. and Health Advances, LLC, or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of foreign currency exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.


LONDON, February 28, 2017 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced the appointment of Simon Harford as Senior Vice President and Chief Financial Officer effective June 1, 2017. He will serve on PAREXEL's Business Review Committee, the Company's senior-most leadership team, and assist in developing and implementing PAREXEL's strategic objectives. Mr. Harford will be based at the Company’s corporate headquarters in Waltham, Massachusetts. “Simon brings to PAREXEL more than three decades of global financial management and investor relations experience in the pharmaceutical industry. During his career, he has successfully managed large global finance functions, implemented transformational projects, and improved operational effectiveness,” said Josef von Rickenbach, Chairman and Chief Executive Officer, PAREXEL. “Simon’s leadership will strengthen our ability to accelerate growth and improve profitability as we implement our corporate strategy.” Mr. Harford joins PAREXEL from GlaxoSmithKline plc (GSK), where he most recently served as Senior Vice President, Finance, for the company’s Global Pharmaceuticals business based at GSK’s global headquarters in Brentford, England. Prior to joining GSK, Mr. Harford served as Group Vice President and Controller for Avon Products, Inc., in New York. Additionally, he spent two decades with Eli Lilly and Company in various finance leadership roles across Europe and in Indianapolis, most notably as Head of Investor Relations and as Vice President and Controller. “PAREXEL has a long and distinguished history of providing innovative services to the biopharmaceutical industry, a record that has positioned the Company for long-term growth,” said Mr. Harford. “I look forward to working with PAREXEL’s management team as we leverage growth opportunities and deliver value to our shareholders.” Mr. Harford, a native of the United Kingdom, holds an MBA from the University of Virginia’s Darden Graduate School of Business. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialisation continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 19,625 employees in the second quarter. For more information about PAREXEL International visit www.PAREXEL.com. PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners. This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. Such factors and others are discussed in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.


BOSTON--(BUSINESS WIRE)--PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced the appointment of Simon Harford as Senior Vice President and Chief Financial Officer effective June 1, 2017. He will serve on PAREXEL's Business Review Committee, the Company's senior-most leadership team, and assist in developing and implementing PAREXEL's strategic objectives. Mr. Harford will be based at the Company’s corporate headquarters in Waltham, Massachusetts. “Simon brings to PAREXEL more than three decades of global financial management and investor relations experience in the pharmaceutical industry. During his career, he has successfully managed large global finance functions, implemented transformational projects, and improved operational effectiveness,” said Josef von Rickenbach, Chairman and Chief Executive Officer, PAREXEL. “Simon’s leadership will strengthen our ability to accelerate growth and improve profitability as we implement our corporate strategy.” Mr. Harford joins PAREXEL from GlaxoSmithKline plc (GSK), where he most recently served as Senior Vice President, Finance, for the company’s Global Pharmaceuticals business based at GSK’s global headquarters in Brentford, England. Prior to joining GSK, Mr. Harford served as Group Vice President and Controller for Avon Products, Inc., in New York. Additionally, he spent two decades with Eli Lilly and Company in various finance leadership roles across Europe and in Indianapolis, most notably as Head of Investor Relations and as Vice President and Controller. “PAREXEL has a long and distinguished history of providing innovative services to the biopharmaceutical industry, a record that has positioned the Company for long-term growth,” said Mr. Harford. “I look forward to working with PAREXEL’s management team as we leverage growth opportunities and deliver value to our shareholders.” Mr. Harford, a native of the United Kingdom, holds an MBA from the University of Virginia’s Darden Graduate School of Business. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 19,625 employees in the second quarter. For more information about PAREXEL International visit www.PAREXEL.com. PAREXEL and PAREXEL Informatics are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners. This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. Such factors and others are discussed in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.


Harapanhalli R.S.,PAREXEL
Seminars in Nuclear Medicine | Year: 2010

In March 2004, the Food and Drug Administration (FDA) published a report entitled Challenge and Opportunity on the Critical Path to New Medical Products in which it explained the critical path to medical product development and called for a nationwide effort to modernize the critical-path sciences with the aim of moving medical product development and patient care into the 21st century. The report identified medical imaging and imaging biomarkers as potential clinical development tools to facilitate medical product development and to help minimize drug attritions and development timelines. Also, in recent years, basic research on receptor-based imaging has led to an increase in the new investigational radiopharmaceuticals, many of which are in basic research stages in academic institutions. It is therefore an opportune time to review the FDA requirements for testing and approval of new radiopharmaceuticals to further the cause of development and approval of newer medical imaging and therapeutic agents. Although the radiopharmaceutical-development process aligns well with the drug-development process for conventional pharmaceuticals, it has its own challenges and unique considerations. For example, unique issues surrounding short-lived positron emission tomography drugs have necessitated revisions and refinements to the existing regulations. The FDA Modernization Act mandate has finally resulted in the publication of new cGMPs (current good manufacturing practice) for positron emission tomography drugs. Often, the radiopharmaceutical community is not well-informed about the regulatory pathways and scientific basis for the regulations they are subjected to. Questions, such as (1) "Do I need an investigational new drug (IND) or can I do my investigation under an RDRC (radioactive drugs research committee) oversight?" (2) "What type of information on radiopharmaceutical product quality is needed for an IND?" (3) "What level of cGMPs I am expected to operate under?" (4) "Do I need a traditional IND or can I perform studies under an exploratory IND?" (5) "What are the IND-enabling pharmacology and toxicology studies?" (6) "Is my practice consistent with pharmacy compounding or do I need to file an application with the FDA?", for example, are a source of confusion to the radiopharmaceutical community. This review provides an overview of FDA's drug development and approval process with special emphasis on radiopharmaceuticals and attempts to clarify many regulatory issues and questions by providing appropriate discussion and FDA references. © 2010 Elsevier Inc. All rights reserved.


News Article | January 26, 2017
Site: www.realwire.com

Simplified, end-to-end solution will help biopharmaceutical clients provide compassionate access to their treatments for patients London, January 26, 2017 – PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today launched an expanded Managed Access Programs service. PAREXEL now offers end-to-end expertise for the design, development, and delivery of managed access programs to help biopharmaceutical companies provide access to investigational medical products for patients in need. Managed Access Programs provide use of an investigational medical product by a patient when enrollment in a clinical trial is not possible. Often called “Compassionate Use” or “Expanded Access,” these programs allow patients to obtain direct and rapid access to a therapy while regulatory or reimbursement processes are still ongoing. A treating physician or patient may request such access in the absence of comparable or satisfactory alternative therapy or when the investigational product presents less risk than the disease or condition for the patient. “Managed Access Programs can be complex to operationalise. They require expertise and experience in managing these types of programs as well as a global network to deliver these solutions with key agencies, regulators, local decision makers, and the medical community,” said Peggy Schrammel, Vice President, Managed Access Programs, PAREXEL. “PAREXEL’s unique configuration of simplified, end-to-end services for Managed Access Programs includes seasoned operational teams, global regulatory expertise, proprietary technology, and global clinical logistics.” In addition to designing all aspects of the program, PAREXEL clinical logistics experts manage the supply of the medicinal product, ensuring on-time delivery and ongoing availability of product for each enrolled patient on a worldwide basis. Leading global safety experts oversee all aspects of pharmacovigilance and reporting requirements of safety events, while market access experts help clients determine the utility of collected data for commercial and medical stakeholders as indications of real world value. PAREXEL’s expanded Managed Access Programs service is available around the world as part of the MyAccessProgramsTM platform, a proprietary technology of PAREXEL. The platform can support multiple Managed Access Programs for a client, including patient identification, physician enrollment, stakeholder communications management, and drug supply management. MyAccessProgramsTM platform also provides clients with real-time progress oversight. About PAREXEL International PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 18,750 employees in the first quarter. For more information about PAREXEL International visit www.PAREXEL.com. PAREXEL and MyAccessPrograms are trademarks or registered trademarks of PAREXEL International Corporation or its affiliates. All other trademarks are the property of their respective owners. This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “should,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. Such factors and others are discussed in the section entitled “Risk Factors” of the Company’s most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.


BOSTON--(BUSINESS WIRE)--PAREXEL International Corporation (NASDAQ: PRXL) announced today that executives will be participating at two investor conferences in March. A live webcast of the Barclays presentation will be available at PAREXEL’s website at www.PAREXEL.com on the Investors / Events and Presentations webpage. A replay of the presentation will be available on the website for 90 days after the presentation. PAREXEL International Corporation is a leading global biopharmaceutical services company, providing a broad range of expertise-based clinical research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, and reimbursement. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices in 85 locations in 51 countries around the world, and had approximately 19,625 employees in the second quarter. For more information about PAREXEL International visit www.PAREXEL.com.

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