What is a Medical Device CRO?
A Medical Device Contract Research Organization is a CRO that specializes in the clinical trial, development, and data management of medical devices specifically.
A Contract Research Organization (CRO) is an organization contracted by another company to take the lead in managing that company’s trials and intricate medical testing responsibilities. Contract Research Organizations reduce the cost of research and development to help businesses and institutions save money while meeting evolving regulatory requirements.
The increased number of medical device trials and the number of regulatory requirements has led to significant growth of the medical device CRO industry. The design and implementation of medical device studies may vary significantly from the studies of pharmaceutical products. Medical device CROs are able to offer services that are specifically designed to meet the trial needs and regulatory requirements that are unique to the development of medical devices.
Medical Device CRO topics covered below include:
- Benefits of Outsourcing to a Medical Device CRO
- What Does a Medical Device CRO Do?
- How to Choose a Medical Device CRO
Benefits of Outsourcing to a Medical Device CRO
Medical device trials bring significant compliance challenges. Outsourcing to a CRO with precise expertise in the development of medical devices has multiple benefits for clinical professionals and institutions.
Meet Complex Regulatory Requirements
Regulatory authorities necessitate complex and exact data in order to approve a medical device. CROs have intimate and intricate knowledge of complex regulatory requirements and audits since they operate within clinical compliance on a daily basis. This enables CROs to be preemptive in addressing any and all compliance challenges.
Save Time and Money
Outsourcing to a CRO will save you vital time in the trial and development phase of your medical device. CROs already possess the necessary resources, tools, and experts required to perform a medical trial, significantly reducing the time it would take to complete a trial in-house. There are also substantial financial savings in hiring a CRO as the cost to keep full-time staff and medical facilities year-round is significant.
The reduction in time and faster trial process offers medical institutions another reduction in cost. Outsourcing to medical device CROs has helped companies reduce their product development cost by 10% to 30%.
Access the Most Advanced Technological Resources
Medical device clinical research is a rapidly evolving industry. It is crucial that all hardware, software, and internet-based applications are of the best quality in order to fast-track clinical trials while still maintaining quality control. Working with a CRO gives the hiring company access to these advanced technological resources, as well as systems for data management, research analysis, product development, and other clinical research services.
What Does A Medical Device CRO Do?
A medical device CRO offers many of the same services as a Contract Research Organization or Clinical Research Organization with the services tailored to meet the needs of medical device development.
Medical Device CROs provide a range of clinical research services for medical professionals and institutions that may include:
- Medical Device Project Management
- Clinical Data Management
- Clinical Study Management
- Research Compliance
- Research Education
- Validation Programming
- Device Development Planning
- Device Commercialization
- Product Registration
- Safety and Efficacy Summaries
- Security Procedures
- Quality Reporting
- Case Report Forms (CRF)
- Statistical Analysis Reports
- Final Study Reports
- Database Lock and Data Transfer
- Database Maintenance and Archival
- Medical Writing
How to Choose a Medical Device CRO
When choosing a medical device CRO, you should consider:
- CRO’s Past Experience
- CRO’s Niche Expertise
- Regulatory Expertise
- Industry Track Record
- Customizable Services
CRO’s Past Experience
When choosing a CRO for medical devices, you want to look for one with specific experience in medical devices that goes beyond general CRO services. Look at a company’s previous experience, including the clients they have previously worked with and the types of projects they have completed.
CRO’s Niche Expertise
Look for a CRO that has experience in the same niche as yours so that they can more closely adapt to meet the exact needs of your clinical device development.
Can the CRO meet the regulatory requirements you need in order to develop your medical product? What experience do they have with regulatory authorities and compliance challenges that could occur? Do they routinely update training and education for their team members? The CRO should ensure everyone on their team is up to speed on all current regulatory requirements, including any recent rules or requirement changes.
Industry Track Record
Based on the projects they have completed and the clients they have worked with, what is the CRO’s track record within the industry? What do other institutions and partners have to say about them and the quality of the services they provided?
Look for a CRO that will tailor its services to meet the specific needs of your medical device development. How will their teams coordinate and communicate with yours? How will they customize their services to meet your needs?
PMI’s Medical Device CRO Services
Promedica Intl. (PMI) delivers the quality and consistent results of a large Clinical Research Organization with the efficiencies and responsiveness of a small CRO. PMI has been the CRO of choice for a variety of medical device clinical research projects for clients ranging from industry leaders to early-stage companies. We offer medical device CRO services that are scalable and customizable to meet your specific needs.
PMI’s quality control procedures for statistical
output involve a combination of independent programming
and internal review to verify accuracy and completeness
of tables, figures, and listings.