Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).

Our model combines the depth and experience level of our people with effective tools and processes already in place that are designed to ensure your critical eTMF documents and content are secure, organized, readily accessible, and always in complete compliance with all relevant regulations.

The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

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.

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.

Get extensive experience developing and delivering quality services for data management departments across all major therapeutic areas and phases for pharma/biotech companies. 

Chief medical officers looking for outsourcing services on a study are often fed lines from large CROs on how they can provide individuals with multitherapeutic backgrounds.

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).

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.

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.