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Clinical Services for Medical Devices
AKRN provides clinical consulting services compliant with ISO 14155:2020.
We have the expertise to set up and manage clinical investigations designed to demonstrate clinical safety and performance of a medical device for CE Marking.
We also provide optimized solutions to obtain post-market surveillance clinical data on commercialized devices.
We specialize in providing CRO solutions that balance quality, timelines, and budget using scientifically rigorous methods.
Clinical Investigation Planning
- Study design, planning & optimization
- Site Nomination
- Clinical Investigation Plan (CIP)
- Investigator’s Brochure (IB)
- Case Report Forms (CRFs)
- Informed Consent Form (ICF)
- Preparation of Study Plans: Monitoring, Data Management, Statistical Safety.
- Ethics Committee (EC) and Competent Authority (CA) Submissions
Clinical Investigation Conduct
- Site Selection/Qualification Visits (SQV)
- Site Initiation Visits (SIV)
- Interim Monitoring Visits (IMV)
- Source Data Verification (SDV)
- Close-Out Visits (COV)
- Study Documentation Control
- Adverse Event (AE) Reporting
- Interim and final database lock
- Data analysis and reporting
Regulatory Services for Medical Devices
AKRN partner with MedTech companies to support them in the regulatory process towards a CE mark certification.
Regulatory Services
- CE Mark Strategic Planning
- Preparation of Technical Documentation
- MDD to MDR Transition
- IVDD to IVDR Transition
- MDR/IVDR GSPR Overview
- Product Classification
- Clinical Evaluation
- Performance Evaluation
- Derma filler (injectable implants) compliance with EU MDR 2017/745
- PMCF/HCP Surveys
- Notified Body Contact
- Person Responsible for Regulatory Compliance (PPRC)
Medical Writing for Medical Devices
Medical Writing and Clinical Reporting
Our extensive experience and therapeutic knowledge are valuable when preparing plans and reports essential for an optimal regulatory strategy. Our services are compliant with ISO14155:2020, MDR 2017/745, and MEDDEV 2.7/1 Rev 4 guidelines.
- Clinical Investigational Plan (CIP)
- Investigator Brochure (IB)
- Clinical Study Report (CSR)
- Annual Safety Reports (APR)
- Clinical Evaluation Plan (CEP) and Report (CER)
- Summary of Safety and Clinical Performance
- Post Market Clinical Follow Up (PMCF) Plan
- PMCF Evaluation Report
Quality Management Services
At AKRN, our expert quality consultants can support medical device manufacturers in developing and implementing a QMS under ISO 13485:2016, in compliance with EU regulations. Our services include:
- Development of QMS documentation according to ISO 13485:2016
- Full implementation of QMS according to ISO 13485:2016
- Internal audits according to ISO 13485:2016
- Gap assessments with prior ISO 13485 versions and EU requirements
- Assistance in resolving gaps identified
Statistical Analysis and Reporting
AKRN partners with MedTech companies as a scientific consultant to develop clinical documentation with a comprehensive design, where deep expertise can help design better outcomes.
Our biostatistics team is specialized in creating accurate and suitable strategies.
- Definition of Study Endpoints, Objectives and Variables
- Development of Statistical Analysis Plan
- Analysis Population
- Sample Size Calculation
- Comparative and Descriptive Analysis
- Development of Justifications and Rationales
- Preparation of Plan and Procedures
Clinical Data Management
AKRN provides clinical data management
We have the expertise to manage data management activities related to clinical investigations and performance studies designed to demonstrate clinical safety and performance of a medical device according to requirements stipulate in the ISO 14155:2020 and ISO 20916:2019.
Our clinical data management team produces results that are verified at the source, delivering the transparency, integrity, accountability, speed, and accuracy you need.
- Design and Development of Case Report Forms (CRF)
- Development of CRF Completion Guidelines
- Data Project Management
- Data Entry, Collection, and Export
- Data Review, Database Cleaning, and Data Queries
- Database Import and Preparation
- Development of Data Management Plans and Procedures
