RFI

MENU

Szukaj

    RFI

    Drop in a message and we will reach out to you

    A camera and a medicinal product, symbolizing the importance of monitoring and capturing safety data during clinical trials. This highlights the role of pharmacovigilance in ensuring patient safety by managing adverse events and reporting serious unexpected adverse reactions (SUSARs). It underscores the responsibility of sponsors to adhere to safety obligations, including submitting reports to Competent Authorities via the EudraVigilance system, and emphasizes SciencePharma's expertise in providing tailored safety management and pharmacovigilance services for clinical trials.

    Pharmacovigilance in Clinical Trials

    Safety management is key to any clinical trial and an utmost obligation to any pharmaceutical company introducing new medicinal products to the market. Whilst conducting a clinical trial, the safety of all subjects is paramount, therefore best efforts should be made to capture any safety issues.

    Sponsor’s Safety Obligations

    Each Sponsor is obliged to submit to among others Competent Authorities (CAs) / via EudraVigilance system all suspected serious unexpected adverse reactions occurring after administration of the Investigational Medicinal Product (IMP) in an expedited manner. An individual Suspected Unexpected Serious Adverse Reaction (SUSAR) is a case report describing an adverse reaction to a subject that is:

    • associated with the use of DMP,
    • considered serious (fulfilling at least one of the criteria for seriousness, i.e. results in death, results in congenital anomalies or birth defects, results in persistent or significant disability, is life-threatening, requires or prolongs hospitalization),
    • considered unexpected – has not been described in the current version of Reference Safety Information and Investigator’s Brochure at the time of reaction onset.
    A calendar with sticky notes displaying deadlines like '60 days,' '15 days,' and others, along with terms such as SUSARs, periodic reports, and DSURs. This visual represents the critical timelines and reporting requirements in pharmacovigilance for clinical trials, emphasizing the importance of managing safety obligations. It highlights the need for timely submission of serious unexpected adverse reactions and periodic safety updates to regulatory authorities, as managed by SciencePharma's expertise in clinical trial safety and compliance.

    Furthermore, timely submission of periodic reports is as important as reporting SUSARs, as of today, the deadline is 60 calendar days from data lock point. Good quality data gathered throughout the concerned period is key for evaluation and providing satisfactory conclusions.

    Why is it worth outsourcing pharmacovigilance in clinical trials to SciencePharma?

    We have considerable experience in the safety management of adverse reactions from clinical trials. Our pharmacovigilance department can create and implement safety procedures. We manage Adverse Events (AE) including case narrative writing and recording in the safety database, together with MedDRA coding. Moreover, SciencePharma’s experts prepare and send follow-up requests, expectedness assessment of Serious Adverse Reactions (SARs), complete standard reporting forms (CIOMS I), report SUSARs to the National Competent Authorities (NCAs), Ethics Committees (ECs), submit SUSARs to EudraVigilance Clinical Trial Module (EVCTM) database, as well as prepare and submit Development Safety Update Reports (DSURs).

    Maintaining safety within clinical trials is of paramount importance to any pharmaceutical company. Choosing an experienced safety vendor is an essential step towards successful clinical trial performance. With our considerable experience, SciencePharma may advise and support clients with PhV services tailored to fulfill safety goals.

    If you want to put the safety of your clinical trials in good hands, please contact us.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.