Clinical Trial Application (CTA) is a Regulatory dossier that is submitted to the Health Authority of the country in which a sponsor would like to conduct clinical trials with Investigational Medicinal Products (IMPs) or with approved drugs to explore new indications. To obtain clinical trial authorization, a CTA application must be submitted with all the required documentation as per the regulations of the competent national Health Authority of a country. Clinical Trial regulations and safety reporting requirements for clinical trials vary from one country to another across the globe. Every country has its own Regulatory framework and enforcement to authorize and monitor clinical trials.
In case of the US FDA, clinical trial application is submitted in the form of Investigational New Drug applications (IND), whereas for MHRA (UK) and the EU Member States, such requirements include submission of Investigational Medicinal Product Dossier (IMPD) along with Clinical Trial Authorization application. For Canada and most of the world countries, clinical trial authorization application is commonly referred to as Clinical Trial Application.
In general, a clinical trial application contains information on quality, safety, & efficacy (or proposed therapeutic uses) of the investigational drug. The level of CMC (Chemistry, Manufacturing and Controls) and safety/efficacy data requirements will vary based on the phase of the clinical trial conducted (i.e. Phase I, Phase II, Phase III). Once submitted, the CTA shall be reviewed by the respective Health Authority. Upon satisfactory review and evaluation of the information submitted in a CTA, the sponsor will receive a formal authorization from Health Authorities to conduct the proposed clinical trials. Regulatory requirements with respect to different phases of clinical trials and the type of study population are divergent in different countries of the world.
General challenges in conducting clinical trials are planning of clinical trials, CTA/IMPD/IND preparation, and submission as per the country specific regulations. In case of global clinical trials (trials in multiple countries), integration of the Regulatory process (CTA applications submission in multiple countries) with clinical material manufacturing/supply logistics & engagement with clinical trial sites is crucial and requires prior experience and thorough knowledge on CTA filing process in each country.
Also, the right Clinical Trial Management System (CTMS) with Clinical Data Management Systems (CDMS) is essential to effectively conduct clinical trials and for clinical data management from multiple trials/sites.
Freyr assists sponsors in planning, preparation, and submission of CTA applications in different countries for different types of medicinal products, such as small molecules, recombinant protein products, vaccines, cellular and gene therapy products, etc.
- Strategic support in identifying the optimal Regulatory approach for CTA submissions and obtaining CTA approvals in multiple countries across the globe (US, EU, LATAM, MENA, Africa, APAC, etc.).
- Gap-analysis of developmental data/submission data against the current Regulatory requirements of different countries for CTA submission, and expert advice on mitigation plans for identified Regulatory issues, submission risks, potential clinical hold issues, etc.
- Authoring, technical review, and submission of clinical trial application for pharmaceutical products, vaccines, biosimilars, and other biological products for most of the world countries.
- Preparation and submission of CTA amendments (CMC & clinical) and annual reports (wherever applicable).
- Regulatory response strategy, preparation, and on-time submission of responses to Health Authority (HA) queries pertaining to CTA submissions.
- Follow-up with Regulatory agencies throughout the clinical trial process.