INSIGHTS ON CLINICAL TRIAL PARTNERING

• Large Global Phase III Clinical Trial In Metastatic Colorectal Carcinoma (mCRC)

  UBC was tasked with managing a large global phase III clinical trial in patients with mCRC refractory to standard chemotherapies. Read how patient enrollment was completed 3 months ahead of schedule and database lock 3.5 months ahead of schedule.

• Top Three Drivers To Improve Study Start-up

  Study start-up has significant impact on the overall speed of a trial, making it one of the most critical parts of the study process. Encouragingly, adoption of study start-up applications is on the rise. Discover the top areas for improvement in today's study start-up processes.

• Back On Track: Data Rescue On Pediatric Rare Disease Trial

  A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was not effectively managing the study data. As trouble mounted, the CRO quit, stranding the project at a critical point in the development cycle. Premier Research was able to step in and successfully take over the data management and statistics portion of the trial to keep the trial on track.

• Compensating Participants In Clinical Research: Current Thinking

  New research on how people make decisions about research participation, and new approaches to the question of payments and compensation to participants, bring a new perspective; are payments to participants actually too low? This paper explores this question, and whether we should, in fact, worry much less about restricting compensation for research participants.

• Breakthrough Therapy Designation And Accelerated Approval With Inadequate CMC Program Development: Hurry Up And Wait

  This article examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s expedited accelerated approval (AA) and breakthrough therapy designation (BTD) programs.

• Provider Selection In Small And Emerging Pharma Companies

  As anyone who has ever attempted to sell clinical development services to pharma organizations can tell you, the task is no mean feat. It is difficult to determine who makes the decisions and who the influencers are. The presence of preferred provider agreements makes it tricky for a new provider to get its proverbial foot in the door. And, of course, every company has a different process for outsourcing clinical development work.

• A New Resupply Strategy Turns An Emergency Into An Opportunity

  Successful clinical trials require accurate demand forecasting, efficient distribution channels and a secure supply chain strategy. Find out how Almac Clinical Services helped one sponsor implement an optimized clinical supply strategy that resulted in an uninterrupted clinical trial and reduced costs.

• How To Boost Disclosure Efficiencies With Outsourcing

  In this webinar, you’ll hear about exciting new advisory and managed disclosure services from TrialScope, including: compliance, policy and process assessments, as well as plain-language summaries, protocol registration, results posting, and redaction services.

• Ashanthi DeSilva’s Story: A Look Back At The First Gene Therapy Trial

  In recent decades, clinical gene therapy trials have underpinned the research that has significantly contributed to advancements in the development of therapies for this and other diseases – and these trials can be traced back to a young girl named Ashanthi DeSilva.