Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles

inspection readiness

[vc_row][vc_column][vc_column_text]Companies have one year to prepare for the CTISThe Clinical Trial Information System (CTIS) went live at the end of January and serves as the single-entry point for clinical trial data under the Clinical Trials Regulation (CTR) within the European Union and European Economic Area (EEA) countries. Companies have one year to prepare for the CTIS, after which any new application must be submitted via the CTIS.

The CTIS will simplify the application process considerably by allowing sponsors to apply for clinical trial authorization in up to 30 EEA countries with the single application. In particular, using an organization-centric approach, as recommended by the European Medicines Agency (EMA), will allow sponsors to oversee their trials.

Harmonization, transparency and consistency

For both sponsors and regulators, the CTIS will harmonize the application and assessment process, improve collaboration and information-sharing between member states and sponsors, increase transparency and the consistency and reliability of information, simplify safety reporting and enhance safety standards for clinical trial participants.

While there are immense benefits for sponsors and regulators, there are many hurdles to overcome. The CTIS requires companies to develop a user management model, however, access rights could become an issue in a variety of situations. These include:

  • If identified users leave the company or CRO
  • If a user doesn’t have access to the CTIS training environment, called CTIS Sandbox, they might struggle to adapt their internal processes
  • If a sponsor works with several CROs they may need to limit access rights to ensure each CRO only has access to documentation for the trial they’re working on

Another key challenge to be aware of is the need to respond to any request for information in the 12-day timeline or risk the trial lapsing. To avoid this problem, companies need a dedicated person to check the system regularly since it doesn’t send automatic notifications to sponsors.

The CTIS does not allow parallel submissions, so if there are requests for substantial modifications while another assessment is ongoing, companies will have to wait, and that could impact the timing of a clinical trial. There are also issues with parallel submissions for multinational trials when documents must be provided in local languages. In these situations, companies are advised to determine whether they want to submit part 1 (the scientific and medicinal product document) and part 2 (the national and patient-level documentation) simultaneously or separately, and whether there are any additional considerations regarding which countries to submit to first.

As with all new systems the time and costs associated with training are inevitably a burden for the organization, but it’s important to ensure training of not only CTIS users but also management to ensure at least a basic understanding of the new processes.

Preparing for a new approach

Many companies are updating their internal processes to align with specific user roles; however, accessing the training environment remains a priority since this will be key to enabling them to update internal processes in alignment with the CTIS.

While large pharma companies have established task forces to prepare themselves and have been more involved in EMA training, many smaller and mid-sized companies are turning to partners for help in establishing correct user roles and internal training and updating their processes so that they’re aligned with the activities in the CTIS.

As they gear up for CTIS, it would be advisable for companies to plan their transitional trials, and prepare for issues that are likely to be time-consuming, including the manual upload of documents – both for publication and those that won’t be published. They should also be prepared for the likelihood that documents previously submitted via the directive may require changes or additions in order to comply with the regulations.

One other important step will be to ensure the company is registered in the Organisation Management Services (OMS) data management service of the SPOR, because CTIS connects to the SPOR database.

In all ways, CTIS and the CTR will require companies to be more organized and have people to drive the overall process.

Phlexglobal, a leading technology and services organization for clinical and regulatory solutions, is conducting a survey into how well-prepared companies are for the CTIS. In January this year, Phlexglobal merged with PharmaLex. To understand your own preparedness, we encourage you to take the Phlexglobal survey.

About the authors:

Milena Shuytsova-Mircheva is Senior Manager Regulatory Affairs at PharmaLex with extensive experience in life cycle management and clinical trials. Lisa Pascoe is Director of Regulatory Affairs at PharmaLex and the International Services Lead for clinical trial applications, overseeing inquiries, projects and resources.

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