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
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…
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