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.
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.
VIDEOS
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![inseption group charge trial thumb]( "Who's In Charge? How To Ensure Effective Trial Oversight, Leadership")
Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.
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![isg whats wrong thumb]( "Uncovering The Root Cause Of Clinical Trial Troubles")
Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.
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![ISG crisis to confidence web thumb]( "From Crisis To Confidence: Ensuring Smooth Regulatory Submissions")
Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.
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![isg safety at center thumb]( "The Synergistic Role Of Drug Safety In Clinical Trial Operations")
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.
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![ISG Practical Applications thumb]( "ICH E6(R3): Practical Steps For Implementation")
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.
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![Inseption]( "Patient Over Process: The inSeption Group Difference")
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.
CONTACT INFORMATION
inSeption Group
800 Adams Avenue
Audubon, PA 19403
UNITED STATES
Phone: (267) 498-5092
FEATURED ARTICLES
- The Power Of AI To Improve Clinical Trial Monitoring
- Why The Regional Site Manager Is The Swiss Army Knife Of Clinical Trial Monitoring
- Successful Regulatory Submission Via The Trifecta Of Awesomeness
- Diverse Mentorship Models Create Multiple Paths To Employee Success
- How To Establish Effective, Scalable Drug Safety Ops Across Vendors
- How To Unlock The Secret To Repeatable, Scalable Low Turnover
- Treating Deficiencies In Employee Training And Mentorship
- Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation
- The Write Side Of AI: Augmenting Capabilities, Not Replacing Them
- Accelerated Development: Gene Therapy Vs. Small Molecule
- The Power And Potential Of RBM In Clinical Trials
- Remote Work Success Is Built On Pre-Site And Site Initiation Visits
- Rare Disease Clinical Endpoints: Ingenuity Meets Practicality
- Gene Therapy Natural History Studies: Benefits, Timing, And Execution
- Biotech Files NDA Following Risk-Based Mock Inspection
- Regulatory Submission Crisis Rescue: When To Take Action
- What Quality Control In Medical Writing Means, And Why It Matters
- Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
- CRAs Must Evolve Alongside Oncology Therapeutics
- Enhancing Autologous Cell Therapy Trials Through Collaborative Protocol Design
MYTHBUSTERS
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![Human resources concept-iStock-1089413486]( "The Great Talent Misconception With Large CROs")
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.
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![Risk indentify crossword blocks -iStock-517223530]( "Is There Really Less Risk In Selecting A Large CRO?")
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.
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![Puzzle idea thinking iStock-1031459576]( "The Fallacy Of The Corporate Memory Concept")
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.
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![iStock-1097275434]( "Do You Take Comfort In Governance Agreements?")
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
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![GettyImages-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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![GettyImages-1288438537 ecosystem]( "Clinical Research As A Delicate Ecosystem")
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.
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![Microscope of cell, Embryonic stem cell]( "Optimizing Autologous Cell Therapy Clinical Trials")
Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.
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![GettyImages-505936413 clinical trials]( "Key Insights For Running A Clinical Trial Smoothly")
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.
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![Business Meeting Future GettyImages-1307086301]( "Think Your Large CRO Can't Fail? Think Again")
Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.
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![GettyImages-1081762792-research-blood-sample-microscope]( "Clinical Trial Risk Management: How To Get The Most Out Of Your CRO")
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.
