news roundup

WCG Acquires Waife & Associates

WCG has acquired biopharma consultancy Waife & Associates (W&A). W&A will continue to provide analysis, implementations and recommendations to address a range of organizational and technology questions around the clinical development process. W&A's Founder Ronald S. Waife becomes WCG's Chief Management Consulting Officer.

Tufts, Avoca Release Industrywide Benchmarks for the Contract Vendor Qualification Process

The Tufts Center for the Study of Drug Development, in collaboration with The Avoca Group, released its results from the first industrywide benchmarks of the vendor qualification process. Highlights include: vendor requalification cycle times are two to four weeks faster, on average, than new vendor qualifications and despite longer total assessment cycle times, large drug companies have the highest rates of vendors failing to qualify (11.5%), likely due to deeper inquiry into vendor practices.

Signant Health, ActiGraph Integrate for Real-World Patient Functioning

Signant Health, formerly CRF Health and Bracket, has integrated its eCOA platform TrialMax with ActiGraph’s CentrePoint system. The integration, which includes ActiGraph’s FDA 510(k) cleared sensors, hopes to simplify the process of collecting and monitoring real-world activity, mobility, and sleep outcomes data for patients and researchers.

Articles

Cardiac Imaging in Clinical Trials

This article examines imaging systems and services since its use is commonly used as a biomarker for safety in oncology development and in many trials is the primary efficacy endpoint.

The Functional Service Provider (FSP) Model Revisited

The understanding of FSP, how it is evolving and how to get the best results from the model still are a puzzle to many, say the authors. For the purposes of this article, we define FSP as an outsourcing strategy where vendors provide a single service (statistics, pharmacovigilance or clinical monitoring, etc.) or a limited number of highly related services (site contracting, site payments, etc.).

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Lisa Henderson
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LHenderson@mmhgroup.com