Acceler8 Clinical Research offers global regulatory consultancy for pharmaceutical and device companies. We have extensive experience across a spectrum of product types, having a proven track record in assisting companies to meet their legislative requirements and having a 100% success rate with clinical trial submissions.
Our established processes facilitate commercial efficiency and cost-effectiveness in helping to bring clients’ development plans to reality and products to market.
Enlisting Acceler8 Clinical Research brings the benefit of comprehensive client-side experience to companies seeking to challenge over-cautious approval strategies which are sometimes an indicator of inadequate broad spectrum Regulatory Affairs experience.
Our Regulatory Affairs and Medical Writing Services include:
- Regulatory Consultancy
- Country-specific strategic planning (preclinical through post-marketing)
- Scientific advice meetings
- Orphan Drug Applications
- Paedriatic Investigation Plans
- Drug Master Files
- Risk Management Plans/Risk Evaluation and Mitigation Strategies
- MDD/MDR & IVDD/IVDR compliance
- Design and Development support
- Verification and Validation support
- Technical File/Design Dossier review
- Pre-Submission meetings
- PMA/510(k) review
- Post Market Surveillance
- International Registrations
Clinical Trial/Clinical Investigation/Performance Evaluation
- Clinical Trial/Investigation design
- Objectives and Endpoints to meet regulatory goals
- Appropriate Inclusion/Exclusion Criteria
- Adaptive Designs
- Trial Authorisation submissions (experience in a wide range of medicines and device submissions in Europe, North America, Australia and Asia)
- Ethics/IRB Submissions
Medical Writing is a fundamental part of clinical research. Our writers work closely with their colleagues in the Full Service, CRA, CQA and DM divisions of Acceler8 to deliver compliant, practical, timely and cost-effective documents to the required ethical and scientific regulatory standards.
Our medical writers integrate with each client’s team by being flexible to their specific requirements and using our vast experience and expertise to ensure quality outputs from every trial and investigation. Acceler8 Clinical Research have a breadth of knowledge and experience drawn from the pharmaceutical and medical device industries as well as healthcare providers and academia. All documents produced by Acceler8 Clinical Research undergo thorough scientific, statistical, editorial and quality control review to ensure expedited regulatory review wherever possible.
Our medical writing services include regulatory and clinical writing, as well as manuscripts for publication, educational material and Medical Writing consultancy.
- Clinical Trial Protocol & Clinical Investigation/Performance Evaluation Plans
- Investigator’s brochure
- Patient Information/Consent Forms
- Recruitment material (posters/websites)
- Labelling (including instructions for use)
- ICH E3 Compliant Clinical Study Report
- Development Safety Update Report
- Patient Safety Narratives
- Clinical and Non-Clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
- ISO 14155 Clinical Investigation Report
- Clinical Evaluation Report
- Performance Evaluation Report
- Technical File/Design Dossier compilation
- PMA/510(k) compilation