IoR & Customs Clearance
The Trial Master File (TMF), the essence of every clinical trial, supports the quality, integrity, and validity of the collected data. With TMF contributors positioned around the globe, there is an obvious need for Clinical Trial Sponsors to look at their eTMF management processes to ensure timely TMF completeness, required quality of documents and inspection readiness of the file.
Multiple service providers typically contribute TMF and it is challenging to ensure high quality and inspection readiness of the TMF across all studies. Also usage of several eTMF management systems may increase the Sponsor’s burden to oversee the status.
IRM allows you to streamline the TMF management process providing the Clinical Trial Sponsor with dedicated, sponsor-focused team for eTMF management process.
Step by Step Guide:
While the number of clinical trials in Ukraine increasing and their efficiency and quality as well, patient recruitment and retention becomes more crucial.
The success of the trial depends on identifying the right patients for the study and their further engagement to invest their time and effort into drug development. Patient recruitment is considered to be one of the most difficult challenges and it is estimated that 80% of clinical trials do not meet their patient enrolment deadlines.
The above-mentioned challenges have led key players in the pharmaceutical industry to seek external support of specialized companies to expedite the patient recruitment and optimize patient retention processes.