Application Notes & Case Studies

  1. Delivering The Global Expertise Required To Coordinate A Pediatric Gene Therapy Trial 5/4/2020

    A European biotech company was conducting a pediatric trial involving a rare, incurable genetic disorder. In addition to new regulatory considerations, this trial also called for an extremely challenging intracerebral administration. To succeed, they needed a partner that could develop a clear, compliant strategy for obtaining informed consent and implementing an innovative data management plan to track patients between surgical and clinical sites.

  2. How Ramping Up Communications Helped Overcome A Next-To-Impossible Recruitment Challenge 4/21/2020

    We knew going in that it could be the perfect recruiting nightmare with extremely complex inclusion/exclusion criteria. By letting sites set their own goals and commit to them along with assigning project coordinators that stayed close to those sites the study is off to a good start.

  3. Clinical Ink And CRO Partner To Create A Disease-Specific Solution To Facilitate Lupus Clinical Trials 4/20/2020

    For sponsors and CROs, clinical trials for systemic lupus erythematosus (SLE or, more commonly, lupus) present a specific set of challenges that can impact the recruitment of investigators and patients and inhibit the ability to collect accurate data. This white paper discusses the challenges of diagnosing lupus, the unique difficulties lupus clinical trials face, and how the innovative eLAS platform helps meet these challenges.

  4. Infectious Disease Teams 4/2/2020

    A not-for-profit Sponsor requested assistance with monitoring in an Ebola hot spot at trial naïve sites with little experience. Ultimately, the study required rapidly deploying solutions across diverse geographies. Read how the quick response and the geographic alignment of the team enabled the study to be completed.

  5. Comparative Analysis For Non-IND Sites 4/1/2020

    A cancer research organization that facilitates the conduct of multi-national clinical trials was deep in the planning and
    coordination of a Phase III drug trial. The sponsor wanted to expand the trial to include German sites and had established important in-country partnerships for this purpose. The trial was being conducted under an IND, and everything was going according to plan until German regulatory authorities changed the rules. Read how Advarra Consulting provided in-depth analysis of German, European, and US regulations, allowing the cancer research study to move forward.

     

  6. From KOLs To Patient Advocates, UsingEvery Tool To Fight A Rare Disease 3/11/2020

    With a recruiting target of 18 patients for a condition that afflicts just one in 31,000 people this CRO had to make full use of what few resources were avaiable. By working with KOLs and a patient advocacy group they located their 18 patients ahead of schedule and completed the 26-week trial early.

  7. Vertex Data Management Team Cuts EDC System Build Times By Half With Veeva Vault CDMS 3/6/2020

    Read how Vertex Pharmaceuticals, Inc. reduced EDC database build times from 13-14 weeks for early phase studies to under 7.5 weeks today.

  8. Advanced Clinical Achieves A Strategic Advantage With Veeva Vault eTMF 3/6/2020

    Contract research organization Advanced Clinical leverages Veeva Vault eTMF to run faster, higher-quality trials for study partners.

  9. Insmed’s Fast And Successful EDC Study Builds With Veeva Vault CDMS 3/6/2020

    Insmed describes the critical success factors enabling them to incorporate significant protocol changes and still hit their FPI deadline with Vault EDC.

  10. A CRO’s Road To ePRO Revenue 3/6/2020

    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.