Pharmacovigilance
Transforming drug safety through innovation and integrated services
From basic medical inquiries to complex adverse event intake, case processing and aggregate reporting, Mediclin Clinical Research provides an end-to-end solution for all of your Pharmacovigilance needs including product safety, medical information and regulatory compliance – all leveraging our global multi-channel, multi-lingual contact centers.
Whether you’re a large pharmaceutical manufacturer, optimizing drug safety across your entire marketed portfolio, or a smaller biotech with a single emerging compound, Mediclin Clinical Research is the perfect addition to your safety strategy.
At Mediclin Clinical Research we offer end to end Pharmacovigilance services including medical contact center, Individual case safety reports, medical reviews, SAE narratives, ADR analysis, regulatory compilation and submission.
We have a team of highly educated and experienced employees which includes Pharmacists (M Pharam, MD – Pharmacology, Pharm D), Doctors (MD Pharmac, MBBS) and Nurses (Bsc. Nursing) to manage each aspect of Pharacovigilance service that we provide.
Our PV Managers and Medical lead keep detailed track of every key metrics of the project so that any issues and gaps can be addressed beforehand and the delays to the project delivery can be avoided. Our Team has experts in case processing, individual case safety reports writing, narrative writing, SAE reports, triage, medical review, signal detection, risk management and report submission to the regulators.
Our expert staff, project management skills, robust processes helps us to deliver the project with highest quality and within preset timelines.
Experienced Medical/PV Writing staff with healthcare degrees and pharmacovigilance experience ensures that PV documents are thoughtfully authored to meet regulatory and PV specifications.
By crafting content, documenting and formatting regulatory reports to meet country specific regulations, WE ensure pharmaceutical, biotech and medical device companies unrivaled safety medical writing documentation.
Your satisfaction matters to us?
We are proud to announce that we achieve our client satisfaction through our seamless process and dedicated resources that are listed down.
Mediclin Clinical Research offers end to end pharmacovigilance services. We have a team of prominent experts including Pharmacists (M Pharam, MD – Pharmacology, Pharm D), Doctors (MD Pharmac, MBBS) and Nurses (Bsc. Nursing). We manage fully functional and comprehensive signal detection process, literature management, safety case processing. Our pharmacovigilance experts perform comprehensive adverse event data intake via multiple channels including the traditional channels. We deliver a specialized safety environment or pharmacovigilance setup implementation in India, USA, Europe, UK
What are clinical research operations skills?
Overseeing the operations of any business is a career in which the right business-minded individual can truly succeed. At its core, the skills needed for a successful career in operations include the ability to think analytically, communicate effectively, and execute efficiently.
Steps For Conducting Clinical Research
- STEP 1: Design Excellent Clinical Research.
- STEP 2: Researcher Preparation.
- STEP 3: Departmental Review & Approval.
- STEP 4: IRB Review & Determinations/Actions.
- STEP 5: Conduct of Research & Reporting.
- STEP 6: Continuing Review.
- STEP 7: Ending the Study.
Clinical operations managers are responsible for overseeing and directing the activities in a medical and healthcare facility. They create work schedules, develop goals and objectives, and maintain records of the clinic’s services.
Research in which people, or data or samples of tissue from people, are studied to understand health and disease. Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease.
Directors of clinical operations have significant responsibilities in planning, directing, and evaluating all medical activities within their facility. Clinical operations directors work with the goal of boosting economical and efficient performance of their medical team while delivering high-quality patient services.
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