Analytics Strategy:

Submissions Readiness Review

Getting Ready to Submit Data

Your clinical trial data is your greatest asset. When it’s time to submit your data, confidence in its regulatory compliance is critical. 

The Submissions Readiness Review by Instem offers the assurance companies need when preparing data for submissions or for building out internal clinical trial data standards aligned to current regulatory guidance. By reviewing your current submission content we offer the expert support you need to successfully follow regulatory standards and increase confidence in the reviewability of your application.

Strategic Consultation

Readiness Video


Expert Knowledge Individualized For Each Client

Staying on top of the current regulatory standards can be difficult for companies and firms with limited industry knowledge and resources. The Submissions Readiness Review was designed to help small- to medium-pharma and biotech companies ensure their submissions meet regulatory requirements from beginning to end.

Reviewing Documents for Compliance

Designed to handle assessments at every phase of the clinical process, the Submission Readiness Review can be used to ensure regulatory compliance at any point in the development timeline, including:

  • Recommending current acceptable data standards required by the FDA
  • Developing a positioning strategy for engagement meetings during submissions
  • Reviewing applications during ongoing submissions
  • Ensuring continued submission compliance, cross-study integrity, and consistency during later stages of various marketing applications (NDA, sNDA, BLA).

After taking a holistic review of all clinical data and existing or planned submission content, our detailed analysis will help ensure that your data aligns with the most current regulatory requirements and that your strategy positions your strengths at the forefront.

Reducing the Risk of Technical Rejection Criteria

Failing to meet standard expectations can result in major delays in your development timelines. Taking the time to review your existing or planned submission can help mitigate the risk of being rejected on a technical or conformance basis.


Expert Knowledge to Strengthen Your Assets

Even the most detailed of teams benefits from a third party perspective. Our Submission Readiness Review is based on experience and an expert-level understanding of the latest updates in regulation expectations. We’re here to make sure that your most valuable assets meet regulatory expectations. This means less worry on rejection, and more focus on the science.

What Makes Instem Analytics Strategy different?

Instem designs and advises on systems and processes that ensure compliance, stimulate workflow efficiencies, and provide a cutting edge in the competitive landscape.

With almost two decades of expertise across life science business, R&D, and IT, our consultants significantly increase products’ speed-to-market, allowing clients to focus on science.

#1: Most trusted clinical technologists and business experts for data-science innovation

  • Independent: Vendor, Software, and Language independence maximizes value to our clients
  • UX based design and prototyping
  • 100+ Life Science, CRO & Medical Device Clients
  • 95% Top 20 Global Pharma Clinical System Modernizations

As of 2018, approximately 30% of organizations are rejected based on technical criteria when submitting applications to the FDA due to a deficiency in their application.