CTIS Submission Planning and Implementation Expert at REAgency+ Available to Offer Support and Solutions
The Clinical Trial Information System (CTIS) is an electronic system that supports the management and submission of clinical trials to regulatory authorities. With the new European Union Clinical Trials Regulation (CTR) come into force in 2022, companies conducting clinical trials in the EU will have to use the CTIS to submit their trial data. As a result, companies are currently integrating CTIS submissions into their processes for clinical trials. Some of the CTIS experiences of the REAgency+ experts in collaboration with a biotech client are presented here.
The company in the case is a US-based biotech company specialising in oncology pharmaceuticals. The company had previously conducted clinical trials in the EU, but had not yet implemented CTIS submission into the company’s processes. Here are some key learnings and lessons learned in the collaboration:
Start early and include delays: implementing CTIS submission processes can be a prolonged process that requires a considerable effort in planning and preparation. The company started planning more than a year before the next clinical trial. Nevertheless, unexpected delays and drawbacks occurred, so that the realisation went on a bit longer than expected.
Working with REAgeny+ experts: Implementing the CTIS submission requires a dedicated team of people who are familiar with the system and regulatory requirements. The company found that it was necessary to allocate additional resources to the CTIS submission to ensure that it could be completed in a timely and efficient manner.
CTIS submission can be a complex process and companies may not have the required expertise. The company found it helpful to work with external experts from REAgency+ who had experience with CTIS implementation and regulatory requirements.
Understanding of legal requirements: The CTIS system is designed to help companies comply with legal requirements, but it is important that companies understand these requirements to ensure that their CTIS submission is successful. The company found it helpful to work with REAgency+ experts to understand the regulatory requirements and timelines. Also, working with investigative sites, required OMS registrations, even though still with some system errors, were completed swiftly and required documents were obtained.
Communication and collaboration with stakeholders: CTIS submission can involve multiple parties within a company such as clinical teams, data management teams, regulatory affairs teams as well as involved stakeholders and vendors. The company found it beneficial, in cooperation with REAgency+ experts, to communicate and collaborate with these stakeholders on a regular basis to ensure that all requirements are met in a timely manner.
In conclusion, CTIS submission can be a complex and time-consuming process, but it is an important step for companies conducting clinical trials in the EU. In conclusion, the standardisation via CTIS submission is considered an advantage for the evaluation and timeline expectation. There are also significantly less documents needed for the submission (Part II). By starting early, allocating resources appropriately, working with experts, understanding regulatory requirements, and communicating and collaborating with stakeholders, companies can successfully incorporate CTIS requirements into their regulatory processes.
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