A double blind, placebo controlled, parallel group, randomized study to evaluate the safety, tolerability, and efficacy of a novel, orally available small molecule for treatment of pain in osteoarthritis (OA).
PRA Health Sciences performed data management activities for this project while the client was responsible for all other services, including site monitoring. When the client reduced the timelines for database lock by approximately 9 months, PRA immediately created a detailed closure plan, listing all tasks and activities that required completion within the given timelines. This plan was reviewed and approved by all parties involved. To successfully complete the closeout period, PRA calculated data flows and trained additional staff members.
In 2005, Abbott sanctioned an executive-sponsored governance body to drive the development and implementation of enterprise-wide study build, data capture and trial management processes using a single electronic data capture (EDC) vendor for all clinical studies. The objective was to quickly move the lion’s share of studies to electronic capture means while maximizing site acceptance.
CTI Clinical Trial & Consulting Services, a full-service global contract research organization (CRO) specializing in complex therapeutic areas, adopted the Medidata Clinical Cloud® as its preferred platform of clinical trial technology to efficiently run the operations of its rapidly growing global business. The company has been using Medidata’s cloud-based platform for over three years.
Why in this day and age, with people connected 24x7 via smartphones and apps, do clinical trials still use paper to capture patient-reported outcomes (PROs)? ePRO solutions have been around for decades, but up to half of studies still use paper to capture patient assessments.
As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations.
Traditionally, clinical trials are paper-based. Patients use written responses to questions and track their daily medical experiences in a written diary. Beyond the awkwardness and inconvenience, when it comes time to aggregate results from all patients to assess results, the manual process of data assembly is time-consuming and prone to errors.
As technology solutions are increasing in adoption in the clinical research industry, ways to maximize their efficiencies are being more closely considered. eSource is emerging as a possible process to remove complexities and deliver time and cost savings to studies. By Niki Kutac, Director, Product Management, DATATRAK
A Phase IIa randomized double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, and tolerability of of Study Drug when given Methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy (DMARD).
A biotechnology company selected PRA’s Clinical Diagnostic Services (CDS) group to conduct a global diagnostic study, which involved validating innovative, non-invasive blood sample test results collected from high-risk pregnant women against the “gold standard” results from amniocentesis or chorionic villus sampling.
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