ABOUT INSEPTION GROUP

inSeption Group is a global full-service outsourcing organization built upon a foundational culture of exceptional service and quality. 

This culture attracts a subset of industry experts who value your assets as much as you do and take personal responsibility for delivering on what has been promised. Our ability to integrate these dedicated professionals into your teams results in unmatched execution and continuity.

inSeption Group offers full-service outsourcing, functional service provider solutions, and consulting services specializing in oncology, hematology, neurodegenerative disorders, rare disease, and cell and gene therapy.

FEATURED SERVICES

Our experienced 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.

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.

CONTACT INFORMATION

inSeption Group

870 W Main Street

Lansdale, PA 19446

UNITED STATES

Phone: (267) 498-5092

VIDEOS

MYTHBUSTERS

  • Large CROs have a vast pool of resources and a subset of amazingly talented people. However, the decision to select such a CRO on the concept that they have access to the best talent, and the hope that those resources will be assigned to your study, is flawed.  

  • Most quantitative and qualitative studies seeking to understand what creates fear and anxiety in humans conclude with some version of the same 4 key criteria: Lack of Control, Large Consequence, Sudden Occurrence, and Unfamiliarity. In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair Contract Research Organization is quite daunting.

  • The theory of Corporate Memory is easy to understand and agree with – the better you record and understand recurring actions the better you will perform those actions. Read why Capitalizing on corporate memory might work at an individual level but is nothing more than a myth and an empty promise in the complex changing world of drug clinical studies.

  • Have you ever asked yourself why you take comfort with governance agreements? They're created to "protect" you when your CRO fails - and even then, what can you realistically do? Find out the answers here.

E-BOOKS

  • Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors.

  • Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.

  • Discover how biopharmaceutical sponsors in clinical trials leverage real-time data analytics and conduct comprehensive gap analyses to improve trial efficiency and overcome study challenges, such as patient recruitment and retention, risk mitigation, and evolving patient expectations.

  • Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.

  • Biopharma companies — particularly smaller or emerging organizations — often are unable to draw maximum value from CROs. This occurs for any number of reasons, several of which are covered in this e-book.