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Mock Inspection Challenge Solution

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At inSeption Group, we can effectively prepare your company for FDA approval and inspection. We can set up a mock inspection of your company, proactively identify any concerns, and help you mitigate the risks along the approval process. Our FDA mock inspection process in the example below is an example of the steps we take to help protect your company’s reputation and your product approval process, and we can do the same for you. (Click here to see our Mock Inspection Challenge Solution PDF for a scanning code.)

 

Challenge

A new, emerging biotech company was preparing to submit their NDA. Anticipating an FDA inspection, they wanted to take a proactive approach to mitigate risks and identify potential concerns.

 

Solution

inSeption Group crafted a risk-based strategy, blending elements of mock inspections, clinical site preparation visits/audits, and review of critical documents (e.g., TMF), processes, and training—designed to thoroughly examine all elements of the company’s clinical studies and Quality Management System.

 

Benefit

With this customized risk-based mock inspection, the sponsor was able to identify and address any potential gaps that could warrant more scrutiny within their application. Working with inSeption Group allowed the sponsor to be ready for every possible scenario, eliminating the stress and anxiety that often results from preparing for an FDA inspection.

 

“We are very, very grateful for your work and collaboration. This was an amazing achievement, and we have all of you to thank! What’s your secret? How do you do this time and time again?

“You are gladiators!”

 

At inSeption Group, we are a full-service global outsourcing solution for guidance through clinical trials. We provide support throughout the clinical trial life cycle, site management and clinical monitoring, as well as medical writing and quality control. Reach out to us today for your clinical trial outsourcing needs.

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We’ve recently published a piece regarding analytics and data science during a clinical trial, written by Nina Anderson at inSeption Group. If you are interested in reading the full article and seeing sources, you can click here to see the PDF, but we’ve included a short synopsis here for you to get started.

Anderson points out that the usage of advanced analytics can assist pharmaceutical sponsors with a multitude of challenges, but that advanced data analytics is critically underutilized for a variety of reasons, including concerns of in-house expertise, return on investment, regulatory scrutiny and other hurdles. Through better understanding of high quality data, Anderson states, the industry can move towards more efficient and well-managed clinical trials and better quality results.

The article explains how the need for quick turnaround in conducting clinical trials often hinders the ability to collect and analyze high quality data. Data must be cleaned and monitored, which is a time-consuming process, partly because of an antiquated method of trial leadership that insists on source document verification (SDV).

As Anderson cites in a real life example, source document verification does not necessarily result in the data in that document being accurate. The end result in this example was multiple mis-stratifications across separate databases. Anderson points out that algorithms designed to catch such discrepancies in real time could have flagged the issue sooner.

The article goes on to explain how part of the issue with data contextualization and analysis is that the data engineers who program visualization tools have little understanding of clinical data, and as a result might not use proper data sets for visualizations. Ideally, Anderson writes, “A more effective approach would comprise having a subject matter expert (SME) in clinical operations who also understands programming, including its available tools and technologies.” Unfortunately, this isn’t an easy option for pharma companies, due to the lack of such SMEs or the cost of licensing fees.

To this end, Anderson does describe free and open source software platforms that can produce effective visualizations, with no need for licensing fees. Posit (formerly RStudio) is one example of such software. Once data has been organized for analysis, organizations can now manually view the output before trusting the data and its conclusions.

Anderson sums up the piece by pointing out the benefits of using the underutilized advanced data collection and analytics, including stopping potential fraud. A pharma company looking for approval through a clinical trial can be better served finding ways to leverage those analytics.

Read More About Analytics and Data Science During A Clinical Trial

To read the piece in full, click here…and to find out more about how inSeption Group can help your company make the most of your analytics and data science during a clinical trial, contact us today.

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Dawn Niccum at inSeption Group published a piece about gap analysis in the clinical trial space; if you are interested in the entire piece you can read the PDF here. The main focus of the article is the significance of the gap analysis regarding a life science organization’s quality management system (QMS).

Among the most prominent shortcomings of the QMS, Niccum points out, is inadequate risk management. If a company is not properly documenting their risk-based approach, the exercise can fail. Document management can also become a prominent concern…a company may not be using a validated system to store documentation, or a system that doesn’t provide user-friendly access to controlled documents. Another potential issue with QMS can be vendor management problems, such as insufficient oversight.

Gap analysis, Niccum suggests, is best performed during the initial entry into a clinic, rather than a later phase of development. It is much easier to make changes, adjust personnel behaviors, and alter procedures earlier in development, ultimately resulting in lower costs and less administrative headaches. As Niccum states, “one cannot retroactively build quality into a process that already has been implemented.”

That said, gap analyses can still provide a true benefit later in the development process, especially if that portion of the process can be up to four or five years. Even late in the development, it can benefit a company to be able to show that it is improving its processes.

One important part of gap analysis, Niccum shares, is the importance of collaboration. An effective gap analysis includes conversations with key personnel, and viewing outputs from standards operating processes. It’s critical to assist a consultant’s understanding of a client’s own awareness of its processes. A gap analysis can then produce a “report card” with areas for improvement.

In summary, while a biopharma might have confidence and faith in its personnel and partners, it’s vital to trust but verify, and ensure that those procedures are being followed. With an effective gap analysis, a biopharma has an insurance policy that they can share with sponsors to build confidence. The end goal, Niccum writes, is “helping a client to a point where they no longer feel they need additional guidance or assistance.”

 

Read More About Gap Analysis In The Clinical Trail Space

To read the article in full, click here. To find out more about gap analysis in the clinical trial space and how it can benefit your organization, contact the inSeption Group today.

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In a recent newsletter, Joseph Arcangelo, the Co-Founder and Managing Partner of inSeption Group, speaks to the importance of establishing effective communication with potential development partners and how CMOs can develop trust between the service provider and biotech team members. You can view this piece in our newsletter here.

 

In the CMO Summit 360 Newsletter, Arcangelo discusses biotech outsourcing solutions and relationship management with service providers in clinical trials. He answers typical questions related to communication and negotiation between CMOs and service providers and stresses the importance of early discussions in negotiations, how to deal with the aggressive timelines of newer biotech companies, and the importance of focusing on even the little details when developing trust between parties.

“It is important the CMO is included in creating tangible and collaborative goals, objectives, and KPIs with your service provider for the clinical trial. When you can embed and integrate the right people, the discussion of the realities of any project becomes a joint effort among credible experts. And frequently, when that occurs, a phenomenon of what was seemingly impossible to consider actually gets completed within the preferred timeline.”

Ultimately, the CMO Summit 360 Newsletter article emphasizes the importance of developing trust in working with service providers on a clinical trial and the need for goal-oriented and effective communication between CMOs and service providers. We hope you’ll take the time to read the piece, and feel free to reach out to us to find out more about our services.

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Multitherapeutic Contract Research Partners

Multitherapeutic contract research partners can promise a great deal to their potential clients—access to vast resources, flexibility, and multiple skill sets within their organization. And in some cases, that might be a good fit for sponsoring a clinical trial. But in other cases, partnering with multitherapeutic contract research partners can ultimately be costly in time, money, and data quality.

Put simply, a jack-of-all-trades organization might not be the best fit when your outcomes require specific needs and critical endpoints. For sponsors researching products that are dedicated to specific and critical conditions, including oncology and orphan disease, it’s far more important for a partner to have specific expertise and experience.

It’s important to remember that a contract research organization (CRO) ultimately has to keep its people billable, and as such, it assigns individuals where it has the most need. As a transition from the “A” team to the “B” team takes place to complete a study, the quality of service and data is ultimately compromised.

In the end, while some CROs can offer a wide array of resources and flexibility and could work well in some projects, it boils down to assigning the right people to work on a study…average resources going where they’re assigned, as opposed to highly skilled experts.

More About Multitherapeutic Contract Research Partners

For a much more detailed breakdown of multitherapeutic contract research partners and whether they are a good fit for your efforts in clinical trials, take a look at this detailed PDF, featuring specifics and statistics regarding the impact of different types of outsourcing organizations.

inSeption Group offers full-service outsourcing focused on oncology, hematology, neurodegenerative disorders, and rare/orphan disease with a specialization in cell and gene therapy. Contact inSeption Group today to find out more about our services, and follow inSeption Group on LinkedIn for the latest updates.