Clinical Trial Technology Editorial

  1. Are Your Clinical Trials Prepared For The Coming mHealth Tsunami?

    Excitement around mHealth technologies has been building for years. While initial apprehension kept many companies from jumping into the space, sensors are finally starting to make it onto patients. In this Q&A, Glen de Vries, president of Medidata Solutions, discusses progress the industry has made, concerns that remain, and what the future holds for mobile and wearable technologies.  

  2. Study Rescue: How To Get Your Clinical Trial Back On Track

    Beth Harper has devoted more than 28 years of her life to the world of clinical research, including time at a sponsor, CRO, service provider, and start-up company while also serving as an adjunct associate professor at George Washington University. She is currently president of Clinical Performance Partners, where she works with companies to optimize study feasibility and site selection and helps to improve site relationship management practices. Although her passion is to work on proactive protocol and site performance optimization strategies, she will tell you that most of her time is spent rescuing studies. In this Q&A, Harper shares her insights on the factors that will lead to a study rescue and what companies can do to prevent that situation from arising.

  3. Duke & PCORI Use EHRs To Transform Clinical Trials

    PCORI (Patient-Centered Outcomes Research Institute) and the Duke Clinical Research Institute have launched the ADAPTABLE study, a patient-centric trial designed to assess the benefits and long-term effectiveness of aspirin dosing. With a budget of over $14 million, the trial will randomize and dose 20,000 patients while leveraging health systems, EHRs (electronic health records), and patients in an attempt to fundamentally transform clinical research.

  4. IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For June 2016

    Below are my top three articles downloaded on Clinical Leader for the month of June 2016. In case you missed them, please take this opportunity to see what everyone else was learning about the clinical tragedy in France, using source data verification as a quality control measure in trials, and where the industry stands on eSource implementation.

  5. GSK’s Bold Move Into Uncharted mHealth Waters

    While some sponsor companies continue to fret over the challenges of incorporating mobile and wearable technologies into clinical trials, GSK is one sponsor that has been boldly moving forward. GSK’s thinking and efforts in this area are certainly attributes that others should emulate.

  6. TMF Survey: Major Changes To Clinical Operations

    Every year Veeva’s Paperless TMF (trial master file) Survey provides insights into the state of electronic TMF (eTMF) adoption in clinical trials. This year marks the third year for the survey, which explores the life science industry’s progress in streamlining clinical trials and efforts to unify clinical operations.

  7. Clinical News Roundup: FDA Issues 3 Final Guidances For Expanded Access

    Clinical news roundup for the week of May 30 2016 with articles on FDA guidance for expanded access, writing an RBM plan, fixing clinical trial reimbursement, rethinking Phase 1 trials, IBM's Watson, and more.

  8. 3 Steps For More Effective Sponsor-CRO Partnerships

    Clinical Operations (ClinOps) leaders increasingly outsource critical components of their trials. By one estimate, 75% of pharmaceutical and biotechnology companies are now outsourcing data management and over 70% are outsourcing site operations. As a consequence of the growth of this practice, effective collaboration between Sponsors and their CROs has never been more critical for achieving clinical trial milestones on-time and within budget.

  9. eSource Implementation: Where Are We Now And Where Are We Going?

    Over the last several years, life science firms have cautiously moved into the eSource arena. While companies look forward to attaining the benefits of eSource, they also have concerns over potential glitches, the impact on study teams, and regulatory issues. 

  10. BMS’ Opdivo Trials: What They Teach Us About Successful Studies

    It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.