Clinical Operations
Clinical operations provides end-to-end support and efficient solutions for every stage of the clinical trial lifecycle, including pre-study, startup, maintenance, reporting, and close-out services to support all clinical study needs.
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Site Management and Clinical Monitoring
Our Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites. Our RSMs can act as a “one-stop shop” for all activities related to a clinical study site.
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Medical Writing and QC
We author and QC all types of regulatory documents, including clinical study protocols, clinical study reports, Investigator’s Brochures, briefing documents, regulatory responses, patient narratives, and Modules 2 to 5 of the eCTD.
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Quality Assurance
We establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.
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Electronic Trial Master File (eTMF)
We utilize Vault eTMF (Veeva Systems, Inc.) to provide unique and scalable solutions to maintain our clients’ eTMF with inspection-readiness practices incorporated into daily operations.
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Regulatory Operations
Our Regulatory Operations (RegOps) team provides submission support in order to proceed with electronic submissions to Health Authorities.
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Biostatistics
The Biostatistics group ensures proper collection, verification, and delivery of clinical trial data through collaborative partnerships.
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Data Management
Our team of industry experts have extensive experience developing and delivering quality services for data management departments across all major therapeutic areas and phases for pharma/biotech companies.
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Contracts and Legal
We focus on handling all corporate legal matters, negotiating Sponsor MSAs, SOWs, and vendor and site contracts/budgets.
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