Premarket Clinical Trial Services
Expert guidance through every phase of your medical device clinical development. From protocol design to regulatory submission, we ensure compliance and success.
Bioexcel's Strategy
Our seasoned physicians and clinical research professionals provide comprehensive support throughout your clinical trial journey.
Clinical Investigation SOPs
Take advantage of our well-established clinical SOPs that ensure compliance with MDR, ISO 14155, and other applicable standards across regulatory jurisdictions.
Healthcare Ecosystem
Healthcare Ecosystem Benefit from our established network of leading hospitals and clinical sites. We help identify, select, and recruit the appropriate sites for your trial.
Expert Team Operating Globally
Our clinical research professionals have published extensively and can assist you in all phases of clinical development across multiple regions.
An Essential Phase
Pre-market clinical investigations are usually conducted to produce clinical data to support clinical performance and/or safety in the context of CE marking. A pre-market clinical investigation, performed on a device not yet CE marked, must comply with the MDR and any applicable common specifications as defined in Article 2(71) of the MDR.
Clinical Research Experts
Manufacturers may lack the internal resources to conduct clinical studies. Outsourcing to experienced professionals helps avoid unacceptable risks and ensures regulatory compliance.
Scientific Board
Acting as an advisory body, our scientific board participates in the development of medical and clinical methodologies/technologies. Members are eminent scientists with proven excellence across disciplines relevant to medical device development.
- Over 100 published scientific papers
- International team of leading KOLs
- Coverage across all key therapeutic areas
Quality Assurance
Ensure your CRO partner holds relevant quality standard documents: ISO14155 (European regulation), ISO9001, and ISO13485 certifications.
Global Capabilities
Does your CRO have global capabilities and partnerships? Working with a full-service organization provides efficiencies like CTMS systems and streamlined vendor management.
Cost Transparency
Compare unit costs and line items fairly. Ensure transparency around pass-through costs that can impact your clinical trial or PMCF study budget.
