Drug Safety Services
With in-depth expertise of safety reporting in clinical studies and post-marketing surveillance, Oviya MedSafe provides comprehensive global drug safety services. From individual customized stand-alone services to diverse complex offerings, Oviya MedSafe provides solutions specific to the requirements of our clients.
End-to-end Processing & Submission of Individual Case Safety Reports (ICSRs)
A Marketing Authorisation Holder has to ensure that any safety relevant information is evaluated properly, adequately and reported subsequently as an ICSR or SUSAR (Suspected Unexpected Serious Adverse Reaction). Complying with global regulatory requirements to fulfil this obligation remains the challenge. At Oviya MedSafe, our team consisting of physicians, scientists, pharmacists and medical data managers offer you our integrated solution for case management which comprises collection of safety relevant data by literature search, assessment of suspected ADRs from the literature, competent authorities and spontaneous reporting systems, followed by electronic reporting.
Aggregate Report Writing & Review (PSURs / PBRERs, PADERs, Clinical Overview Documents & DSURs)
The recent past has seen Pharmacovigilance regulations becoming more stringent, placing various regulatory obligations on the Marketing Authorisation Holders. One of such stern obligations presses for more importance to be given to aggregate reports as these best help define the benefit-risk balance of medicinal products. Oviya MedSafe offers complete and customized support in preparing and reviewing aggregate reports. The Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports & Development Safety Update Reports, prepared by our staff, present the safety information in a remarkable way that easily endorses the proper evaluation of the Benefit-Risk profile. These reports are prepared according to ICH requirements and filed with regulatory agencies per their regulatory norms.
Preparing PSURs for Submission to the Drug Controller General of India
With the office of the Drug Controller General of India making it mandatory for Marketing Authorisation Holders to submit Periodic Safety Update Reports of new drugs, the challenge remains in the form of limited guidance available in Schedule Y. At Oviya MedSafe, we adequately define the procedures for conducting pharmacovigilance activities and provide innovative regulatory-compliant solutions to pharmaceutical companies marketing their products in India.
Comprehensive Pharmacovigilance Service Packages for the RoW Region
Relative unavailability of expertise, differences in regulatory requirements and limited budget allocations for Pharmacovigilance activities remain a huge challenge within the ‘Rest of the World’ (RoW) countries. With stringent global regulations, adoption of international standards for Pharmacovigilance practices by Marketing Authorisation Holders in these fast-emerging RoW region sees obligations in terms of service provision and policy development. Oviya MedSafe’s comprehensive cost-effective Pharmacovigilance service packages for the RoW region offer outsourced Drug Safety support to pharmaceutical companies and Pharmacovigilance Consulting expertise to drug regulatory agencies as well as Marketing Authorisation Holders.
EU Qualified Person for Pharmacovigilance (EU QPPV) & Local Responsible Person (LRP) Services
The European Economic Area requires its Marketing Authorisation Holders to appoint a European Union Qualified Person for Pharmacovigilance (EU QPPV) who will oversee the company’s Pharmacovigilance system. Acting as a central agent to fulfil all key functions, EU QPPV is required to have full understanding of all aspects of Pharmacovigilance. We at Oviya MedSafe provide European Union Qualified Person for Pharmacovigilance service through our adequately trained personnel. Our clients can be rest assured as we are committed to ensure this critical service is well met by our reliable and highly qualified experts. Under the European Union directives, national competent authorities may request the nomination of a contact person for Pharmacovigilance issues at national levels, reporting to the EU QPPV. Appointment of a Local Responsible Person and the scope of the role depends on the Pharmacovigilance setup of the Marketing Authorisation Holders. Oviya MedSafe can guide you with detailed information and assist you by deputing our Local Responsible Persons, for complying with the applicable regulatory requirements.
Signal Detection, Assessment & Management
Safety signal detection remains a crucial mode of monitoring and maintaining the safety profile of products. Signal detection strategies and expert service can help in evidence-based risk management. We understand that identifying new potential risks and developing risk minimization action plans can help prevent these risks. Signal analysis being the core of any Pharmacovigilance activity extends to the entire life-cycle of the product. Oviya MedSafe offers industry-recognized best practices in Signal Detection, Assessment and Management through our expert advice and prompt services in all aspects of signal detection.
Medical Device Vigilance
Medical device manufactures are required to maintain the safety profiles of their products using a proper system in place for postmarketing surveillance. Medical device vigilance seeks to avoid all incidents and related risk involving medical devices. At Oviya MedSafe, we offer you our services by programming regular supervision; development and implementation of the management tools; recording, analysis and processing of information obtained.
Global & Local Literature Monitoring
Literature Monitoring is an integral part of Pharmacovigilance activity meant to proactively screen the published reports. Any medical or scientific evidence available which pose a safety concern generating hypotheses about possible adverse effects may need further screening. Adopting to suit global and local requirements, we at Oviya MedSafe focus on quality and leverage our medical expertise to manage literature screening in a cost-effective manner. Through systematic literature review, Oviya MedSafe offers comprehensive medical overview to help make evidence-based decisions and identify important signals.
Risk Management Plans (RMPs) & Risk Evaluation and Mitigation Strategies (REMS)
The importance of risk management has increased dramatically with the European Union Pharmacovigilance Legislation making it mandatory for every new medicinal product to have an Risk Management Plan (RMP). Having a RMP in place allows for a proactive approach to better understand and optimize the benefit-risk balance of the medication. The challenge here is to make it clear between important identified risks and important potential risks. Oviya MedSafe offers to assist you in the preparation of safety action plan to characterize the adverse experiences, taking necessary steps to communicate and further manage those risks. United States Food and Drug Administration (US FDA) requires Risk Evaluation & Mitigation Strategies (REMS) from Marketing Authorisation Holders to ensure that the benefits of their product outweigh its risks. REMS with Elements To Assure Safe Use (ETASU) may include a risk management process that directs manufacturers on how to address product risk-related goals with tools or interventions to mitigate the risks and ensure strict adherence to product labelling. Oviya MedSafe provides end-to-end solution for risk management and expert support to help manufacturers meet post approval regulatory commitments for risk assessment and risk minimization.
Clinical Trial Safety Management
Clinical Trial Safety Management remains one of the challenging tasks, given the current complex regulatory environment. It is imperative that we adopt proven methodologies and best practices for managing the adverse event case workload. From clinical trial safety to post-marketing surveillance, Oviya MedSafe provides comprehensive drug safety services.