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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Pharmacovigilance
Our Pharmacovigilance team is responsible for the management of safety reporting and the development of SUSARs and DSURs. Our aim is to enhance patient care and safety and to support sponsors by providing reliable, balanced information relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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