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Clinical trial safety
Maintaining safety within clinical trials is of paramount importance to any pharmaceutical company wishing to bring new products to the market place or diversify your existing products. Compliant pharmacovigilance procedures during your pre- and post- marketing clinical trials are key to the eventual success of those trials and the granting of any Marketing Authorisation. Demonstrating this compliance requires a very specific set of skills to be constantly updated in line with regulatory changes.
Why Choose PrimeVigilance To Manage Your Clinical Trial Safety?
Pharmaceutical companies around the world face ever greater challenges in their quest to bring new drugs to market, including:
- Meeting strict budget requirements
- Ensuring staff have sufficient time available.
- Ensuring those staff have the core competences needed.
Ensuring that outsourced activities are appropriately managed and of high quality
You need to conduct clinical trials, and the safety aspects of these involve a plethora of skills to be deployed in a timely manner to ensure not only regulatory compliance but also that best drug safety practices are enforced. Resources may not be immediately available within the company and you may be working within the EU or any given global location. While contracting-in external resources to provide pharmacovigilance services may seem a more obvious choice for medium-sized pharmaceutical companies, the challenges nonetheless remain for even the largest of corporations.
For example, will you have the full range of resources, personnel, skills and time consistently available throughout the studies to satisfy the increasingly complex global regulatory frameworks – in a cost effective manner?
Medical Review & Reporting
Our Clinical Trial Safety Services recognise the need to demonstrate your commitment to safety to regulators, your shareholders and stakeholders and the general public on an on-going basis. In addition to routine processing of individual case safety reports, we provide a comprehensive medical review of cases from your trials which meet with both good practice standards and regulators expectations.
We can also:
- Compile and prepare your reports to trial investigators and Ethics Committees.
- Report to regulatory authorities – within the EU and around the world
- Prepare signalling reports, Drug Safety Update Reports and IND Annual reports
Failure to implement and follow adequate reporting practices can at best result in costly and time consuming remedial work in order to satisfy the needs of the regulatory authorities. It can jeopardise or delay your product’s application for Marketing Authorisation. It can also place your product at risk of losing its authorisation during the post-marketing phase. It is of course necessary to establish and follow adequate Standard Operating Procedures in order to perform your ongoing monitoring of clinical trial safety but it is also essential to have an adequate understanding of the complexities of international regulations and pharmacovigilance laws in relation to clinical trials. Our services include:
- Working with you to establish your SOPs on clinical trial pharmacovgiilance – available for every step of the processes involved, helping you to establish clinical trial data safety monitoring boards if these are required
- Developing your Risk Management Plans in full compliance with EU & worldwide drug safety regulations
- Writing the Development Core Safety Information for each investigational product, if this is considered necessary by your company
- Preparing and submitting your Development Safety Update Reports
- Preparing and submitting your IND Annual reports if required
- Supporting you to asses risk-benefit ratios throughout the trial Updating your Investigator Brochure as necessary
An industry-standard safety database
You need your database to be fully capable and compliant when it comes to managing serious adverse events from clinical trials. All of the above services are supported by our validated ARISg safety database. Our expert personnel have years of experience using ARISg which has become the Pharmacovigilance Industry gold standard. Alternatively, we can use your own safety database and enter data on that system.
Our services include:
- Entering individual cases into the database
- Database searches, retrieval and presentation
- Registration with Eudravigilance Clinical Trial Module
- Code break and submission of expedited reports world-wide
Whether you require particular advice on individual aspects of clinical trial safety or a comprehensive package of support services to allow your trial to operate, we can help you .
To find out more, simply call our team in complete confidence on +44 (0) 1483 307920. We look forward to helping you achieve your pharmacovigilance goals in a far more cost effective way in the short, medium and longer term.