Regulatory and Clinical Services
Our regulatory and clinical services are customized to your requirements.
Yes, we provide traditional CRO services, but we can also help you design your clinical study to meet your intended endpoints. Plus, our European-wide Key Opinion Leader network enables us to help you recruit the best possible sites for your study.
On the regulatory front, we've practically memorized the Medical Device Regulations and can navigate your company through these unchartered waters.
CLINICAL SERVICES
- Post Marketing Clinical Follow-up (PMCF) studies for marketed devices
- Pilot clinical trials -investigational devices
- Pivotal clinical trials for investigational devices
- Clinical Evaluation Plans and Clinical Evaluation Reports
- Performance Evaluation Plans and Performance Evaluation Reports
- Materiovigilance
- Strong knowledge of EU MDR and IVDR
- Well versed with India Medical Device Rules
- Good understanding of ICH E6 and ISO:14155
- ISO certified for QMS & ISMS
- Experience with a range of Medical Devices Class I, IIa, IIb and III, including coronary stents, sutures, orthopaedic implants, surgical instruments, lenses, EM wave therapies, dermatology devices.
CLINEUNOIA TEAM IS WELL VERSED WITH
- Site Initiation Visits
- Clinical Trial Monitoring
- Investigational Product Management and Accountability
- Clinical Trial Supplies Management
- Resolving Data Queries
- Identifying Corrective Actions to Prevent Issue Recurrence and Preventive Actions to Avoid Deviations
- Study Close-out Visits
CLINICAL TRIALS PROJECT MANAGEMENT
- Clinical Trial Project Planning Including Feasibility Assessment, Regulatory Strategy, and Financial Planning
- Selection of Countries & Clinical Trial Applications to Competent Authorities
- Vendor Selection and Logistics Management
- Site Selection & Qualification
- EC Dossier Preparation, Submission and Approvals
- Efficient Patient Recruitment Strategies
- Investigator Contract Development and Grant Negotiation
- Site Set-Up
- Investigator Meeting
Clineunoia Team has
Experience with
- Clinical Trials of all Phases
- Phase I to Phase IV and First in Human Studies
- Small Molecules, Biologics, Biosimilars and Medical Devices
- Global Clinical Trials
- Across Therapeutic Areas
