Application Notes & Case Studies

1. One Source Drives One Process For Clinical Trial Transparency
   10/4/2018

   Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.

2. Improving Compliance While Reducing Resources
   10/4/2018

   A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).

3. A Multiple Sclerosis Clinical Trial Collaboration
   10/4/2018

   Managing multiple outcome measures and rapid patient recruitment for Phase IIB clinical trial on targeting relapse-remitting Multiple Sclerosis

4. Syncing Transparency Processes To Improve Clinical Trial Compliance
   10/3/2018

   The Sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.

5. A Top 10 Sponsor Improves Trial Data Quality Through EDC eSource Solution
   9/4/2018

   Be viewed as an industry leader while at the same time benefiting from higher quality data and a need for fewer resources with use of an innovative eSource solution.

6. Solution Provider Submits Periodic Adverse Drug Experience Reports (PADERs) For A Multinational Specialty Pharmaceutical Company
   9/4/2018

   Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.

7. Pharmacovigilance As-A-Service (PVaaS) Provides Key End-To-End Support To Meet Pharmacovigilance Needs For A Specialty Pharmaceutical Company
   9/4/2018

   PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.

8. Taking On Both Animal Health And Human Clinical Trials With One eClinical Platform
   8/18/2018

   How a CRO is leveraging the eClinical versatility necessary to succeed in a broad array of studies.

9. New Temperature Management Strategy Ensures GDP Compliance And Patient Safety For Large Pharma Company
   8/9/2018

   In the world of clinical trials and GxP activities, without documented evidence of an event, you cannot confirm what really happened. Learn how one large pharmaceutical customer, at risk of non-compliance to GDP due to a downturn in temperature data, improved their monitor compliance upload rate.

10. Cellular Therapy Studies: 7 Common Challenges
    8/1/2018

    Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized such as stem cells (such as mesenchymal stem cells) and cells from the immune system (such as regulatory T cells (Tregs)) from either the patient or a donor.