Post-Market Safety & Compliances
"Advancing Post-Market Drug Safety with Data-Driven Insights, Global Regulatory Intelligence, and Strategic Risk Management"
ICSR intake, processing, and submission
“Efficient Pharmacovigilance for Timely Safety Reporting.”
The ICH`s Good Pharmacovigilance Practice guideline expects all Marketing Authorization Holders (MAHs) to `take appropriate measures in order to collect and collate all reports of suspected adverse reactions associated with medicinal products for human use originating from unsolicited or solicited sources.
The backbone of any safety processing system is the collection and processing of individual case safety reports generated from unsolicited data collection systems. At Clini Resource, we adhere to the highest standards of pharmacovigilance in line with ICH and GVP guideline. Our dedicated staff excels in processing individual case safety reports from diverse sources, including regulatory, literature, spontaneous, and clinical study.
Leveraging world-class safety databases such as ARGUS and ARIS Global, we ensure the seamless management of safety data. For sponsors looking for smaller-scale solutions, we also offer a customised in-house safety database, which has been validated to maintain due compliance with all international safety regulations.
Global and local literature monitoring
“Ensuring Comprehensive Safety Surveillance and Compliance”
MAHs are expected to monitor the global and local scientific literature of their products on a regular basis to identify the adverse reactions for reporting to health authorities. In pharmacovigilance, a comprehensive literature search is imperative for both global and local contexts to ensure a thorough understanding of the safety profile of medicinal products.
A global literature search involves examining international databases, publications, and scientific journals to identify safety-related information from diverse geographic regions. This broad approach is crucial for capturing a wide spectrum of adverse events and trends, enabling a more robust safety assessments, regulatory compliance, and the continuous monitoring of the benefit-risk profile of medicinal products throughout their lifecycle.
CliniResource offers complete literature monitoring services, tailored to client needs. Our professionals conduct worldwide literature searches using Embase and Pubmed, creating strategic search for ICSR detection, aggregate report preparation, signal management, RMP, and other medical writing activities.
Signal detection and management
“Proactively Identifying and Managing Safety Risks.”
A signal is any information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of aknown association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.
The existing pre-marketing/clinical trial procedures provide very limited information in terms of safety and efficacy of a drug, which is just about enough to obtain regulatory approval for drug marketing. Due to this, regulators in the post-marketing scenario often look for higher risk-based approaches to ascertain the benefit-risk profile of a product.
Greater the volume of data, greater the chances of regulatory happiness, but greater also are the chances of risks in the larger unexposed patient population. The balance is extremely precarious, and thus reliance on effective signal detection and management activities becomes the key factor in any effective pharmacovigilance system.
Our team at CliniResource has delved deep into the intricate circuitry of drug safety systems, considering variable regulatory requirements globally and have come up with an innovative and proactive signal detection strategies using advanced analytics and data mining techniques. This can involve continuous monitoring of safety data to identify potential signals of emerging safety issues.
Our medics conduct in-depth analyses of various sources, including regulatory websites, published literature, database listings, and product surveillance programs and submit as valid standalone signal notification as applicable.
Eudravigilance and MHRA Portal Services
“Streamlined Safety Reporting, Enhanced
Compliance.”
Navigating the complexities of pharmacovigilance reporting through Eudravigilance and the MHRA Portal is essential for maintaining compliance with European and UK regulations. Accurate and timely submissions and downloading authority cases ensure patient safety and facilitate efficient communication with regulatory authorities. Our experts are well versed and certified with day to day portal activities, for example,
- Portal registration and administrative responsibilities
- Processing and submission of individual safety reports, ensuring that all adverse events are promptly reported within regulatory timelines
- XEVMPD management – Management of authority cases – Repository Management
- Portal Oversight
At CliniResource, we differentiate ourselves by offering end-to-end portal management with a focus on compliance, speed, and accuracy.
PSMF/National PSMF
“Ensuring Regulatory Compliance and Safety Management.”
PSMF is a legal requirement in the UK, EU and many other countries across the world and is applicable to any authorized medicinal product approved in the territory.
At CliniResource, we recognize the indispensable role of the PSMF within the European Union and other jurisdictions where a similar document is mandated, be it in electronic or manual form. We specialize in the meticulous preparation, thorough review, and ongoing maintenance of PV System Master Files, ensuring complete compliance with EU guidelines or local regulatory requirements.
Our dedicated team is proficient in crafting PSMFs with comprehensive annexures, covering all essential aspects in accordance with regulatory guidelines. Our commitment extends to offering PSMF services to clients, irrespective of whether they avail our pharmacovigilance services. We understand the unique needs of each client and tailor our approach accordingly.