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BioClinica, Inc., formerly Bio-Imaging Technologies, Inc., founded in 1990, is a Pennsylvania-based company that supports pharmaceutical and medical device innovation.BioClinica’s initial service was medical imaging for clinical trials. It is used to capture, collect, control quality, provide blinded reading services to the final delivery to the sponsor company and to the FDA or EMEA if required for medical images in a wide range of imaging modalities. Wikipedia.

Hellio Le Graverand M.-P.,Pfizer | Clemmer R.S.,Pfizer | Brunell R.M.,Pfizer | Hayes C.W.,Virginia Commonwealth University | And 2 more authors.
Seminars in Arthritis and Rheumatism | Year: 2013

Objective: Using placebo data from a recently completed disease-modifying osteoarthritis (OA) drug trial, we seek to inform study design of future radiographic studies. Methods: Eligible patients aged ≥40 years, with body mass index (BMI) 25-40kg/m2 and symptomatic knee OA diagnosed by modified Kellgren and Lawrence grade (KLG) 2 or 3 and pain/stiffness and/or use of medication for knee pain in the past year, were assessed by radiography using a modified Lyon-schuss (mL/S) protocol for joint space narrowing (JSN) (primary outcome variable) at baseline and weeks 48 and 96. Multifaceted quality control was conducted throughout. Repeat images were requested when the medial tibial plateau (MTP) was not aligned (inter-margin distance [IMD] >1.5mm) or for other quality issues. Data are given mean ± standard deviation. Results: Patients (74.9% female; 61.3 ± 9.1 years) had BMI 31.6 ± 4.1kg/m2 at baseline; 222 (173 females) had KLG2, 264 (191 female) KLG3. A significant loss in joint space width (JSW) from baseline to week 48 (-0.13 ± 0.36mm) and to week 96 (-0.22 ± 0.45mm) was observed for all randomised placebo patients (p < 0.001 for both), and at both time points when stratified by KLG2 or KLG3. Standard deviations were small relative to mean changes, providing standardised response means for all placebo patients of 0.35 (week 48) and 0.48 (week 96). Conclusions: Using a tightly controlled radiographic technique, JSN is a viable outcome variable for determining disease progression in mild-to-moderate knee OA. The mL/S protocol is a sensitive and feasible method for OA studies aiming to assess rate of JSN in the knee. © 2012 Elsevier Inc.

Binkley N.,University of Wisconsin - Madison | Bolognese M.,Bethesda Health Research | Sidorowicz-Bialynicka A.,Synexus SCM Sp. Z O.o. | Vally T.,Synexus Clinical Research Centres SA | And 5 more authors.
Journal of Bone and Mineral Research | Year: 2012

The Oral Calcitonin in Postmenopausal Osteoporosis (ORACAL) study was a randomized, double-blind, double-dummy, active- and placebo-controlled, multiple-dose, phase 3 study to assess the efficacy and safety of oral recombinant calcitonin for treatment of postmenopausal osteoporosis. A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray, synthetic salmon calcitonin (ssCT) nasal spray (200 IU/d) plus placebo tablets, or placebo (placebo tablets plus placebo nasal spray), respectively for 48 weeks. All women received calcium (≥1000 mg/d) and vitamin D (800 IU/d). Women randomized to oral rsCT had a mean ± SD percent increase from baseline in lumbar spine bone mineral density (BMD) (1.5% ± 3.2%) that was greater than those randomized to ssCT nasal spray (0.78% ± 2.9%) or placebo (0.5% ± 3.2%). Lumbar spine BMD change in those receiving nasal calcitonin did not differ from placebo. Oral rsCT treatment also resulted in greater improvements in trochanteric and total proximal femur BMD than ssCT nasal spray. Reductions in bone resorption markers with oral rsCT were greater than those observed in ssCT nasal spray or placebo recipients. Approximately 80% of subjects in each treatment group experienced an adverse event, the majority of which were mild or moderate in intensity. Gastrointestinal system adverse events were reported by nearly one-half of women in all treatment groups and were the principal reason for premature withdrawals. Less than 10% of women experienced a serious adverse event and no deaths occurred. Overall, oral rsCT was superior to nasal ssCT and placebo for increasing BMD and reducing bone turnover. Oral rsCT was safe and as well tolerated as ssCT nasal spray or placebo. Oral calcitonin may provide an additional treatment alternative for women with postmenopausal osteoporosis. Copyright © 2012 American Society for Bone and Mineral Research.

Shepherd J.A.,University of California at San Francisco | Schousboe J.T.,University of Minnesota | Engelke K.,Friedrich - Alexander - University, Erlangen - Nuremberg | Engelke K.,BioClinica | Leslie W.D.,University of Manitoba
Journal of Clinical Densitometry | Year: 2015

There have been many scientific advances in fracture risk prediction beyond bone density. The International Society for Clinical Densitometry (ISCD) convened a Position Development Conference (PDC) on the use of dual-energy X-ray absorptiometry beyond measurement of bone mineral density for fracture risk assessment, including trabecular bone score and hip geometry measures. Previously, no guidelines for nonbone mineral density DXA measures existed. Furthermore, there have been advances in the analysis of quantitative computed tomography (QCT) including finite element analysis, QCT of the hip, DXA-equivalent hip measurements, and opportunistic screening that were not included in the previous ISCD positions. The topics and questions for consideration were developed by the ISCD Board of Directors and the Scientific Advisory Committee and were designed to address the needs of clinical practitioners. Three task forces were created and asked to conduct comprehensive literature reviews to address specific questions. The task forces included participants from many countries and a variety of interests including academic institutions and private health care delivery organizations. Representatives from industry participated as consultants to the task forces. Task force reports with proposed position statements were then presented to an international panel of experts with backgrounds in bone densitometry. The PDC was held in Chicago, Illinois, USA, contemporaneously with the Annual Meeting of the ISCD, February 26 through February 28, 2015. This Executive Summary describes the methodology of the 2015 PDC on advanced measures from DXA and QCT and summarizes the approved official positions. Six separate articles in this issue will detail the rationale, discussion, and additional research topics for each question the task forces addressed. © 2015 The International Society for Clinical Densitometry.

Le Graverand M.-P.H.,Pfizer | Clemmer R.S.,Pfizer | Redifer P.,Pfizer | Brunell R.M.,Pfizer | And 6 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objective: To determine if inhibition of inducible nitric oxide synthase (iNOS) with cindunistat hydrochloride maleate slows progression of osteoarthritis (OA) Methods: This 2-year, multinational, double-blind, placebo-controlled trial enrolled patients with symptomatic knee OA (Kellgren and Lawrence Grade (KLG) 2 or 3). Standard OA therapies were permitted throughout. Patients were randomly assigned to cindunistat (50 or 200 mg/day) or placebo. Randomisation was stratified by KLG. Radiographs to assess joint space narrowing (JSN) were acquired using the modified Lyonschuss protocol at baseline, week 48 and 96. Results: Of 1457 patients (50 mg/day, n=485; 200 mg/day, n=486; placebo, n=486), 1048 (71.9%) completed the study. Patients were predominantly women; 56% had KLG3. The primary analysis did not demonstrate superiority of cindunistat versus placebo for rate of change in JSN. In KLG2 patients, JSN after 48 weeks was lower with cindunistat 50 mg/day versus placebo ( p=0.032). Leastsquares mean±SE JSN with cindunistat 50 mg/day ( -0.048±0.028 mm) and 200 mg/day (-0.062±0.028 mm) were 59.9% (95% CI 6.8% to 106.9%) and 48.7% (95% CI -8.4% to 93.9%) of placebo, improvement was not maintained at 96 weeks. No improvement was observed for KLG3 patients at either time-point. Cindunistat did not improve joint pain or function, but was generally well tolerated. Conclusions: Cindunistat (50 or 200 mg/day) did not slow the rate of JSN versus placebo. After 48-weeks, KLG2 patients showed less JSN; however, the improvement was not sustained at 96-weeks. iNOS inhibition did not slow OA progression in KLG3 patients. Clinical trial listing: NCT00565812.

Research and Markets(http://www.researchandmarkets.com/research/g5h9sp/irt_market) has announced the addition of the "IRT Market Dynamics and Service Provider Benchmarking" report to their offering. This report benchmarks 26 IRT vendors (including in-house systems) across 20 different system attributes based on user experience. Anticipating that integration would be a challenge with eClinical technologies, ISR decided to take the unique approach of benchmarking IRT vendors' integration with 20 EDC vendors, 14 ePRO vendors, and 29 CTMS vendors. This provides a closer look into the eClinical space, focusing not only on use and selection but on integration as well. eClinical technology is an area of the clinical development market that this research industry expects will continue to grow while also consolidating. Many of the questions answered in this report offer projections regarding the utilization of IRT services as well as what sponsors would like to see improved as the IRT market moves forward. How you can use this report: The data and conclusions drawn in this report offer value to both sponsors and CROs that outsource IRT services as well as the vendors currently offering eClinical IRT solutions. Due to a large portion of this report focusing on the integration capabilities of IRT systems, this report also provides value to those companies with EDC, ePRO, and CTMS systems as a means of understanding which of these systems are being integrated most often with which IRT systems. Key Topics Covered: 1. Copyright and Usage Guidelines 2. Introduction 3. Report Benefits 4. Methodology and Sources 5. Executive Summary 6. Vendor Perception & Selection 7. Outsourcing Trends 8. Adaptive trial support 9. Trends in Integration 10. IRT Study Data 11. Vendor Attribute Performance and Integration Capabilities 12. Demographics Companies Mentioned - ARIS Global Gxchange IRT - Almac (IXRS, AXCESS, WEBEZ) - Avaya - BioClinica Trident - Cenduit - Criterium Telediary - EPharmaSolutions - Endpoint Pulse - Five9 IVR - ICON IcoPhone - In-House Developed IRT Systems - Medidata Balance - Merge Healthcare - IVR / IWR - Oracle Health Sciences IRT on Demand - PAREXEL Informatics Clinphone - PPD - Premier Research - S-Clinica - Suvoda IRT - Usan Voicenet - Veracity Logic - WCT Smart - Westat Westrax - inVentiv Health Clinical IRT For more information visit http://www.researchandmarkets.com/research/g5h9sp/irt_market

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