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

  • Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

  • In part two of this webinar series, presenters focus on avoiding potential risks such as unexpected budget changes and unplanned change orders that could jeopardize the success of a clinical trial.

  • Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

  • Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.

  • Mitchell Katz, SVP, global clinical operations, has “been there, done that,” when it comes to making decisions about trial control arms, which comparator to use, or the number of patients needed in a first-in-class drug development program. Katz shares his process and thinking here.

  • Patient organizations are important sources of information for trial protocol design. Jessica Powell, VP, clinical operations at Alto Neuroscience, talks about how small and midsize companies without a large commercial organization can engage patients and trial investigators to improve trial performance.

  • Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.

  • How should drug developers think about biomarkers in trial protocol design, particularly in neurodegenerative diseases? Jessica Powell, VP, clinical operations at Alto Neuroscience, shares her thoughts and experiences.

  • Drug developers should use a “model-informed drug discovery and development” program, which can help developers simplify the protocol design process, says Michael Krams, chief quantitative medicine officer at Exscientia.

  • How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.

  • Designing a clinical trial protocol that exhibits the value of a new drug is central to bringing innovative treatments to market. Listen in as experts share tips for ensuring no missteps go unnoticed.

  • Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.

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.