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Clinical Research

Clinical Regulatory

Plan the regulatory checkpoints for your clinical study to improve the quality of regulatory documentation and secure timely approval​

Wherever you plan your clinical studies, we provide you with a full team of expert regulatory consultants, with knowledge at the forefront of innovation and compliance.

We can accompany you from the definition of your Clinical Trial filing strategy and planning, through identification and controls of regulatory requirements, up to submission and correspondence with evaluating bodies, including the critical step of response to evaluation queries from both health authorities and EC/IRBs.

Check our Clinical OperationsBiometry, and Clinical Safety capabilities to give life to your clinical studies.​

Partner with highly qualified regulatory consultants and savvy subject matter experts, mastering clinical research and your technology’s specificities

Whether you are developing a medicinal product (small molecule, biologics, ATMP, live biotherapeutics, GMO), a medical device (hardware and/or software), or a combination of these, it is in VCLS’ DNA to combine regulatory and science to make challenges into opportunity.

Our regulatory specialists team up with in-house subject matter experts (CMCnonclinicalclinicaldata privacymarket accesspatient engagement, and more) to support your program with the review and development of core study and product documents (study protocol, quality/technical documentation, investigator’s brochure, consent documents), and application package components.

Ensure compliance with applicable standards and reduce the risk of evaluation queries with VCLS’ Legal Representation and Compliance Partner services

Wherever you conduct your clinical studies, the local framework may require you to be represented locally.

At VCLS, we offer legal representation services alongside with regulatory support for clinical studies in the EU, the United Kingdom, and importantly providing a US Agent to meet the regulations for ex-US sponsor’s conducting trials in the US under a US IND. Furthermore, VCLS relies on a trusted network of partners to coordinate local representation.

At the forefront of every groundbreaking regulatory change, we are proud to align with non-EU sponsors acting as both a Legal Representative and a Compliance Partnerproviding a finely calibrated set of services to ensure compliance with every key aspect of the EU/EEA framework during the critical steps of preparation and start-up of clinical trials. Similarly, for EU-sponsors we offer a knowledgeable regulatory team to serve not only as US Agent, but to provide both regulatory strategy and submission logistics, recognizing, unlike in EU for CTAs, the FDA’s electronic/eCTD requirements even at the pre-IND stage.


Can I convert my IND into the EMA’s CTR?

Not literally.

The FDA’s US IND and the EU CTR support the same purpose: authorizing clinical trials with medicinal products.

Their technical format is significantly different. While the IND is published to the FDA under eCTD format, a clinical trial application (CTA) in the EU under the CTR must be processed through the online platform called Clinical Trials Information System (CTIS). This format mostly relies on data/information entered into the system’s forms, as well as a number of documents, generally in PDF format.

However, their content can be similar to some extent. For example: the study protocol, compliant with ICH standards and designed with international purpose, can be the same. Also, Quality data (Module 3) of the IND can be converted into the European Investigational Medicinal Product Dossier (IMPD).

The authorization and oversight of clinical trials is the responsibility of EU/EEA Member States while the European Medicines Agency (EMA) is responsible for maintaining CTIS. The European Commission (EC) oversees the implementation of the Clinical Trials Regulation.

With CTIS, sponsors can now apply for authorizations in up to 30 EU/EEA countries at the same time and with the same documentation: all EU member states (to date 27 countries), as well as the EEA member states, adding up Norway, Iceland, and Lichtenstein, to a total of 30 countries concerned.

The United Kingdom (UK) and Switzerland (CH) are not concerned by the EU CTR and operate clinical trial applications under their own national disposals.

CTR transitional application must be approved before 30 January 2025 EOB CET.

An expedited transition procedure will remain open until 16 October 2024 focussing on the validation of minimum application dossiers restricted to documents already authorised under the CTD. After this date and depending on the MS workload, an expedited procedure may not be available.

VCLS invites sponsors with eligible trials to make CTR transition their priority early in 2024 as steps may be required before being able to submit the transitional application. Learn more in our blogpost.

The regulation anticipates in applicable timelines that member states concerned can issue queries (called Request For Information, RFI) during the evaluation of CTR transitional applications.

However, considering that these procedures involve the submission of a set of documents previously evaluated and approved by the member states concerned, the EMA expects the occurrence of RFI during transitional applications to be unusual.

VCLS’ experience so far has proven this effectively occurred, more than sporadically, and we invite sponsors to not bet only on the best-case scenario (and timeline) when planning their CTR transition.

Yes, documents submitted by the sponsor as part of the transitional application do fall under the transparency requirements of the CTR and have to be made publicly available.

Compliance with CTR transparency provisions (management of public disclosure and protection of private personal data, PPD, and commercially confidential information, CCI) generally implies the submission of redacted and sanitized versions (for public disclosure) in addition to full versions of CTA documents (reserved to evaluators, hence not for publication).

These mechanisms shall be considered as of the transitional application considering that all eligible data and documents in the CTIS will be concerned by the public disclosure policy applied by the CTR.

The CTR (European Clinical Trials Regulation, EU 536/2014) is applicable to all clinical trials with medicinal products (drugs). To some extent, the provisions of the CTR may be applicable to non-approved or off-label authorized medicinal products used in clinical investigations for medical devices, or some drug-device combination products.

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