INSIGHTS ON CLINICAL TRIAL TECHNOLOGIES

• A CRO’s Road To ePRO Revenue

  A global, full-service CRO had looked at the increasing demand and expected growth rates for electronic patient reported outcome (ePRO) technology and determined that the opportunity for an ePRO offering would be significant. This case study describes how a global CRO successfully added ePRO to its service offerings enabling them to provide a unified service to its sponsor clients while creating a new revenue stream for themselves.

• Good Pharma Scorecard: See What The Top 5 Sponsors Have In Common

  The Good Pharma Scorecard, as its acronym suggests, is the industry GPS for clinical trial transparency. See what this year's top-ranked sponsors all have in common.

• MHRA’s GCP Findings: It’s About Oversight

  Hone in on the critical findings around the TMF and recording/keeping of essential documents.

• Summary, Critical Details, And FAQ For Your TMF Management

  The EMA’s final “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic)” provides stakeholders with guidance on TMF creation, management, and archival. This overview summarizes and interprets the EMA’s “Guideline on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic).”

• Successful Wearable Device Selection For The Evolving Clinical Trials Landscape

  The number of wearable, connected medical devices (wearable devices) available for use in healthcare and clinical research has increased significantly over the past few years, making it difficult for clinical trial sponsors to determine
  which devices to use in their clinical trials. This white paper is an introduction to the emerging adoption of wearables in clinical trials.

• The Complex Issues With Developing A Novel Human Antibody From Scratch

  Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.

• Vault eTMF Demo: Managing TMF Completeness

  See how Vault eTMF drives efficiency and accuracy in managing TMF completeness.

• Importance And Requirements Of Study Results Posting

  In addition to laws requiring disclosure of clinical trial results, the public also demands this information. TrialScope Chief Strategy Officer Thomas Wicks explains why sponsors should share study results.

• Challenges And Opportunities In Clinical Data Management

  Breakthrough medical interventions are nothing without accurate, comprehensive clinical trial data. Unfortunately, in today’s high-pressured, fast-paced clinical development environment a huge challenge exists with the cleanliness, completeness and quality of clinical trial data. This recent survey of professionals involved in clinical data management at large pharma companies, biotechs, device developers and CROs based around the world provided valuable insight.