|ENBRIDGE COACH HOUSE CHURCH ROAD WOOLTON HILL NEWBURY, BERKSHIRE RG20 9XQ United Kingdom
Medanta was co-founded by the principal consultants in MWB Consulting in 2007, bringing together the technologies of Assured Information Services (PV-Works™) and the pharmacovigilance operational and consulting expertise of MWB Consulting. In April 2009, Medanta was acquired and brought fully into the MWB Consulting fold, enabling considerable international pharmaceutical R&D, medical affairs and business expertise to be leveraged. Today, that expertise makes us unique amongst drug safety service providers and is regarded by our clients as a highly desirable value-added reason to work with Medanta.
Our service is aimed primarily at small to mid-sized biopharmaceutical and medical device companies, where the cost of meeting the increased regulatory and legal burden of monitoring the safety of products during clinical trials and post-marketing demands an efficient and reliable provider of a global drug or device vigilance system.
Our specialist knowledge, technology platform, and a commitment to exceed regulatory expectations ensure our clients have a fully compliant and reliable safety system at a reasonable price.
When working with you we promise you the following:
Accuracy: Ensuring rapid identification of key safety issues, and producing high quality analysis and solutions.
Reliability: Constantly monitoring quality objectives to ensure compliance metrics are second to none.
Integrity: Only taking on work when we can meet our own stringent standards and those of our clients and regulatory agencies. Our communication with you will always be open and honest with an accurate and reliable perspective regarding your product’s safety whilst always aiming to protect your product through its development and commercialisat
Clinical Product Safety Services:
Writing the safety section for the trial protocol Training the clinical trial staff and investigator site staff on pharmacovigilance requirements Design of Case Record Forms and SAE reporting forms Provision of a central contact point for reporting of SAEs Case receipt, data entry, triage, MedDRA coding, narrative writing, medical review, quality control and reporting of cases to agencies Automated production of line listings for signal detection, trend analysis and risk management Writing of FDA annual reports and EU annual safety reports Management of your companies registration with EudraVigilance Provision of the responsible person for EudraVigilance Safety review and sign off on final clinical study reports Set-up, management and participation in Data Safety Monitoring Boards Preparation of safety sections for the Investigator Brochure Electronic reporting to EudraVigilance clinical trial module using an established gateway Utilisation of our own or client-specific SOPs
Post-Marketing Product Saftey Services:
Design, implementation and provision of a global, regulatory-compliant pharmacovigilance system supported by full documentation and SOPs; Management of ICSRs from all sources; Provision of a central “hot-line” telephone number and e-fax capability; ICSR receipt, data entry, triage, MedDRA coding, narrative writing, medical review, quality control and reporting of cases to agencies; Literature search and review; Registration of your company with EudraVigilance Post-authorisation module; Provision of the European QP for pharmacovigilance and deputy with comprehensive 24-hour on-call facilities; Signal generation, detection and trend analysis using our proprietary technology (PV-Trends™); Preparation and submission of PSURs and PADERs; Preparation of risk management plans; Design and implementation of risk minimisation activities; e.g. PASS and patient registries; Managing interactions with third-party organisations and commercial partners; Benefit/risk assessment and management of safety issues; Representation and negotiation with regulatory agencies; Preparation for agency pharmacovigilance inspection; Auditing of pharmacovigilance systems, including pre-inspection audits.
PV Design and Consultation Services:
Evaluation of your current pharmacovigilance system and/or provider with the aim of identifying changes required to meet current regulatory and legal requirements
Preparation for electronic reporting and test reporting to European Competent Authorities Crisis Management Training in pharmacovigilance Preparation and assistance with third-party Safety Agreements Design and implementation of pharmacovigilance systems Preparation of essential documents and procedures, e.g. SOPs Advice on product labelling and interactions with regulatory agencies Advice on company core datasheets and company core product information Advice on risk management Independent analysis and interpretation of product safety issues.
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