Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• How To Run Successful Clinical Trials In Japan

  Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. 

• A Successful Pre-IND Enabling Next Stage Of Development

  Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.

• Testing For Coexistence In Crowded And Contested RF Environments

  In this paper, we review some of the key research, development, test and evaluation (RDT&E) challenges that arise when developing and deploying systems that need to operate in congested and/or contested RF environments.

• Benefits Of Implementing EDC & Medical Coding With RTSM

  Discover what happened when the Fountayn Platform, including RTSM, was used to support a client’s two-year, Phase III study seeking a cure for multiple sclerosis.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Supporting A Company In Manufacturing The RSM For Treating A Rare Tumour

  A clinical-stage oncology company needed a partner to manufacture the RSM. Examine how an optimized RSM manufacturing process helped deliver safe, effective treatment on an accelerated timeline.

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• What Does An Endpoint Adjudication Committee (EAC) Do?

  This white paper discusses the EAC’s role in research, the basics of setting up an EAC, and regulatory context on why it is so important for the committee to be completely separate from study conduct.

• AqueoUS Vets Named A Manufacturing Partner For A Southern CA Water Treatment Facility

  In August 2018, Aqueous Vets was selected over existing industry incumbents to supply the Granular Activated Carbon Systems (GACS) for a Southern California Water Treatment Plant.

• Healthcare System Maintains Compliance Via Internal Program Assessment

  After conducting a clinical research operations assessment, see how healthcare administrators were able to ensure compliance and maintain critical funding sources.

• Real-World Data Capture With EDC

  This case study explores how a Ph.D. candidate partnered with Castor to develop software that seamlessly moves RWD between hospital systems and Castor’s EDC.

• Navigating A Manufacturing Transfer During Global Disruptions

  Manufacturing transfer difficulties as a result of inadequate communication or supply chain disruption can be minimized or eliminated through transparency and collaboration.