Maintaining Safety Within Clinical Trials Has Proven a Challenge to Pharmaceutical Companies
Maintaining safety within clinical trials should be of paramount importance to any pharmaceutical company. The key to success during your pre and post-marketing clinical trials is compliant Pharmacovigilance procedures. Demonstrating this requires competence and skill, as well as the consistency that is required to remain in line with regulatory authorities.
When it comes to managing serious adverse events (SAEs) from clinical trials, it is imperative to have a reliable database which will maximise your compliance.
Our services include:
- Database searches, retrieval and presentation
- Entering individual cases into the database
- Code break and submission of expedited reports world-wide
- Registration with Eudravigilance Clinical Trial Modules
Whether you need a comprehensive support services package or expert advice on individual aspects of clinical trial safety to allow your trial to operate, we are here to help.
Our Clinical Trial Safety Services Team recognise the need to show your safety commitments to regulators, your stockholders, shareholders and the general public.
In addition to the standard processing of individual case safety reports, we can provide you with a medical review of cases from your trials which meet both regulatoratory expectations and good practice standards.
We can also:
- Report to regulatory authorities – within the EU and all over the world
- Prepare signalling reports, Drug Safety Update Reports and IND Annual reports
- Compile and prepare your reports to trial investigators and Ethics Committees.
In addition to this, our services include:
- Preparing, writing and or submitting your Development Safety Update Reports
- Preparing and submitting your IND Annual reports if required
- Working with you to establish your SOPs on clinical trial Pharmacovigilance, available for every step of the processes involved
- Developing your Risk Management Plans in full compliance with EU & worldwide drug safety regulations
- Supporting you to asses risk-benefit ratios throughout the trial
- Updating your Investigator Brochure as necessary
Why Choose Almond Pharma?
Pharmaceutical companies around the world face big challenges when introducing new drugs to the market. Other than demonstrating the safety profile of the drug, many are challenged in an array of areas including staff compliance and meeting budget requirements. Our trained team know and understand how important it is to work in excellence for the purpose of delivering a reputable service for your business.