inSeption’s Clinical Operations and Project Management subject matter experts are integrated into the client’s project team, thus ensuring a more streamlined approach to providing the required support and/or recommending ways to achieve new efficiencies.

We support our corporate sponsors by providing both assessment and processing of SUSARS as per local and country requirements. We provide reliable reporting of adverse events, unbiased signal detection, and potential mitigation and risk management plans, based on any findings as requested. 

We manage all aspects of contract and template development, alternative language and budget parameter development, contract negotiations and execution, as well as investigator grant payment administration and patient reimbursement.

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. Dedicated in our belief that each client should have their own unique tailored experience, quality is the center of all activities. 

Gain insight into how inSeption Group’s Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites and acting as a “one-stop shop” for all activities related to clinical study sites.

inSeption provides medical writing services as well as strategic submission planning expertise to ensure that your application is of the highest quality. Our highly experienced, fully dedicated team integrates with your organization to credibly manage the complexities of timeline creation and management, resourcing, document interdependencies, and transmission through the Electronic Submission Gateway (ESG).

Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system, we can oversee all technical aspects for submission of your dossier. 

Experienced quality assurance professionals establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.

Discover inSeption Group's eTMF success process designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

Ensure proper collection, verification, and delivery of Clinical Trial data through collaborative partnerships. inSeption partners with other organizations who share in our commitment to quality and exhibit proven expertise and the ability to provide high quality deliverables on time and within budget.