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.
Aggregate Report Writing
Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.
In-depth analysis of the benefit risk ratio of a medicinal product or of a medical device is our key strength. With the phasing out of the old periodic safety report template and the introduction of the new PBRER template in the EU, regulators across the world are more focussed on the post marketing safety and risks of a product, since benefits have adequately been demonstrated during the clinical trial phase of development. This makes aggregate reports more risk-focussed.
We offer aggregate report writing and medical review services for aggregate reports for all regulatory geographies of the world.
Signal detection and management
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 a known 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.
We at Clini Resource have especially delved in deep into the circuitry of drug safety systems, keeping in mind variable regulatory requirements across geographies, and have come up with innovative solutions to meet your needs. Our trained staff have in-depth knowledge of regulatory differences in terms of pharmacovigilance requirements. We offer pre-authorization signalling/literature monitoring services, along with regular post-marketing signal management. Our team of medics is capable of performing in-depth analyses of various sources for signal generation, like regulatory websites, published literature, database listings and product surveillance programs.
Literature monitoring services
We offer complete literature monitoring services to interested clients. These services include monitoring of worldwide literature for purposes and on frequencies demanded by clients. We search Embase and Pubmed for our literature monitoring activities. Our professionals are trained on creation of literature search strategies for ICSR detection, aggregate report preparation, signal management, RMP preparation and for all medical writing activities. Evaluation of literature articles for all purposes is also undertaken in-house.
Literature monitoring is also offered as a stand-alone service. This includes evaluation of literature abstracts for molecules or devices authorized for clients, and also assessment of full text articles for preparation of article summaries.
Quality management services
Our in-house quality management system makes sure that we are always on our toes when it comes to quality and compliance. Core pharmacovigilance professionals are involved to ensure the expectations. Regular internal audits ensure that our trainings, SOP reviews and document management are up-to-date so that we are always audit-ready for our clients and regulators.
Everyone who is inducted into the organization is thoroughly trained on our internal quality procedures to ensure complete client satisfaction and regulatory compliance.
As we at Clini Resource understands that quality management system is a backbone for an organisation and is the most complex system which faces the most ignorance, we also offer customised quality management services to our clients by understanding their need.
Risk management plans/REMS/ Safety update reports writing
These specialist documents are the one with most confusion and lack of clarity. Where REMS are moreover MedGuides and or Communication Plans, EU RMPs are more detailed and in some instances additional safety measures may be required in which case a Risk Minimization Plan is required. This may lead to large number of regulatory returns with many requests for update and expansion.
We at Clini Resource are well experienced, facing and respondingsuch challenging requests. Out therapeutic area experts assist in preparation of these tricky documents, and help our client to reach at the maximum satisfaction of relevant Regulatory Authority.