PrimeVigilance and its consultants bring a wealth of experience to the interpretation of case reports within the necessary pharmacovigilance legal frameworks. Our expertise ensures your submissions to regulators are always compliant and on time. The following outlines just some of the reasons why companies choose our staff:
Serious adverse events (SAEs) must be reported to the regulatory authorities within very strict timelines. During any clinical trial, the onus is on your company to explicitly specify for the investigator which events are deemed serious and unexpected within your clinical trial. Your investigator must also make you aware of specific types of non-serious adverse events or laboratory findings. All clinical trial Suspected Unexpected Serious Adverse Reactions (SUSARS) must be reported to regulators within 7 days if they are classified as fatal or life-threatening. Those which are non-fatal, non-life-threatening must be reported within 15 days.
Expedited reporting requirements dictate that your standard operating procedures (SOPs) must involve the accurate grading of events within a suitable timescale. Our staff have the experience to advise on the grading process to ensure accurate and timely compliance. Their input is also crucial when it comes to demonstrating your analysis of risk-benefit ratios.
Since majority of late phase clinical trials involve a double-blinded protocol, your team will need to understand how to appropriately un-blind the trial before engaging in expedited reporting. It is also vital that the correct personnel undertake this task to prevent jeopardising the integrity of the trial and/or presenting non-compliant data to the authorities.
You will also need to demonstrate an adequate and compliant causality assessment procedure when completing your case processing for clinical trials.
As your trial progresses, you will need to demonstrate the continual evaluation of risk-benefit balance, enabling you to determine whether or not to allow the trial to continue. Where companies have outsourced part or all of the tasks associated with the trial, for example to a 3rd party Contract Research Organisation (CRO), the responsibility for correct Case Processing for SAEs still lies with the company as far as the regulations are concerned. Suitable SDEAs (Safety Data Exchange Agreements) and/or Safety Management Plans (SMPs) must be in place and must have been agreed and established accordingly.
You will need to keep detailed records on all clinical trial related data including regulatory submissions which can be reviewed on request by regulators during inspections. For other purposes such as: the marketing authorisation application itself, product Pharmacovigilance Master System File (PMSF), etc. your staff will need to be trained and kept up to date on EudraVigilance terminology used in all reporting. Comprehensive SOPs must be in place to cover these operations.
Non-compliance can result in costly remedial processes to complete tasks that should have been completed correctly in the first instance. It can even pose risks to the product’s ability to reach or stay on the market due to simply having presented data in a way which does not meet the regulations. To find out more about our clinical trial safety services, call us today in complete confidence on +44 (0)1483 307920. Our support is provided by consultants who have assisted on regulatory authorities; those who have worked for years within the pharmaceutical industry and now help companies navigate the complex waters of pharmacovigilance laws.
For more information contact PrimeVigilance today
Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’). 2011/C 172/01)
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