Clinical Trial Consulting
With over 20 years of experience, Apotech’s clinical research experts offer tailored support across trial design, regulatory submissions, and protocol development. We balance compliance with practical implementation to optimise study success across stakeholders.
Our clinical trial consulting services include:
- Study design and protocol development
- FDA IDE submission and Protocol Summary
- Health economics and reimbursement planning
- Literature review
- Pre-IDE interactions with FDA
- Statistical analysis plans
- Resource planning
- Clinical Investigation Plan
- Investigator’s Brochure
Trusted by top-tier teams worldwide
Featured case studies
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…