Our Services

We are a full-service global outsourcing company that provides unrivaled solutions to today’s outsourcing challenges. inSeption has experience working within all therapeutic areas, with a deep expertise in Oncology, Hematology, Neurodegenerative Disorders, and Rare/Orphan Disease with a specialization in Cell and Gene Therapy.  No matter your indication, inSeption can

Clinical Operations
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. LEARN MORE
Site Management and Clinical Monitoring
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. LEARN MORE
Medical Writing
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. LEARN MORE
Quality Assurance
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. LEARN MORE
Electronic File Master File
Electronic Trial Master File 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. LEARN MORE
Regulatory Operations
Regulatory Operations Our Regulatory Operations (RegOps) team provides submission support in order to proceed with electronic submissions to Health Authorities. LEARN MORE
Data Management and Biostatistics
Biostatistics The Biostatistics group ensures proper collection, verification, and delivery of clinical trial data through collaborative partnerships. LEARN MORE
Data Management
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. LEARN MORE
Contracts and Legal
Contracts and Legal We focus on handling all corporate legal matters, negotiating Sponsor MSAs, SOWs, and vendor and site contracts/budgets. LEARN MORE
Pharmacovigilance
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. LEARN MORE