Different regulatory stipulations will apply depending on the region in which you intend to perform your clinical study, the invasiveness of the study procedures as well as the investigational device, product, or procedure. The regulatory environment is continuously evolving and changing, which needs to be considered with each initial or later submission, e.g., in the case of a study amendment. In Europe, implementing the Medical Device Regulation (MDR) and the Clinical Trials Regulation (CTR) have changed the application processes and timelines for clinical studies enormously.
A CRO offering Regulatory Affairs Services related to the Clinical Trial Application (CTA) should be well-positioned in the following aspects:
Solid and in-depth knowledge of the current legislation and regulatory processes. It will not be sufficient to have read the legally binding text of an e.g., medicinal products act. The responsible persons should also be accurately and continuously trained on the logistic and operational aspects.
A sufficiently powered Regulatory Affairs team that can guarantee availability in case of urgent requests. The timelines for answering an authority’s or Ethics Committee (EC)/Institutional Review Board (IRB) request might be short, and immediate action will be necessary.
Team Spirit instead of silo thinking:
Good logistics within the clinical trial team. A Regulatory Affairs Manager will be an indispensable team member and needs to interact with other functions for the collection of documents to be submitted as well as information to answer authority or EC/IRB questions correctly.
Sovereign oversight over the CTA processes running in parallel in the submission and approval phase. Especially in multinational, multiregional clinical trials, this task will demand a high grade of professionalism.
As a Sponsor, you should consider the following key success factors:
When selecting a CRO for (or including) services related to Clinical Trial Applications, it is advisable to consider the following aspects:
1- You as a sponsor must be clear and conscious about the invasiveness and entrepreneurial goal of your planned study.
Be aware that invasive clinical studies demand completely different regulatory processes than non-invasive, observational studies. Furthermore, for clinical drug trials and medical device studies, different routes will apply, and these will also differ depending on whether the study results will be needed for registration purposes. Thus, it seems reasonable to include these aspects in your risk assessment.
2- Identify the geographical region where you want to run your study also based on regulatory aspects.
In multinational studies, different legal requirements and timelines will be demanding and will probably lead to a staggered study start, thus resulting in an overall study delay. Be smart in your regulatory strategy! E.g., in the European Economy Area (EEA), the introduction of the Clinical Trials Information System (CTIS) platform for drug trials aims at harmonizing the approval processes for a simultaneous study start in the participating countries.
3- Make sure that the CRO personnel are adequately trained and informed.
Verify that the CRO personnel responsible for the CTA-related tasks had the relevant training. It is worth reviewing during your qualification audit whether the current legislation is known, and quickly available to all team members, e.g., in a knowledge database. And: Is that database well-maintained and kept up to date?
4- Can availability be guaranteed – also on the sponsor’s side?
The timelines during the approval processes might be tight. It must therefore be assured that the CTA responsible personnel on CRO’s and sponsor’s side will be available when a request for information is received. In a joint effort with clear communication pathways, the goal of receiving approval for your clinical study will be within reach.
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Autor: Dr. Christoph Ortland, November 2023
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