Clinical Trial characteristics of Medical Device/IVD
Medical device products are diversified in product type and model. Products are rapidly upgraded, and are usually found throughout diverse clinical fields. Clinical medical devices are also required to comply with the ‘Norms on the Quality Management for the Clinical Trials of Medical Devices’, ISO14155 and various clinical trial-related regulations.
Due to the particular nature of medical devices, the requirements regarding the clinical team’s knowledge, learning ability, research experience, and overall project risk control capabilities are substantial. The efficacy of medical devices depends to some extent on how well the doctor operates them. Especially for implantable devices, the results may differ completely if the device is operated by different medical professionals. It is recommended to appoint dedicated staff that is familiar with the device to be present during the performance testing or surgery. In turn, this requires trained CRAs equip with a certain degree of surgical knowledge. The trained CRAs benefits your clinical development because, besides understanding surgical records and operations, they also increase the chances of discovering potential device issues and can communicate with the investigators of your study effectively and professionally.
In vitro diagnostics products vary greatly from regular medical devices and often involve the application of associated instruments. Additionally, there are significant differences between China, the US, and Europe regarding classification and registration of in vitro diagnostics product. In clinical trials of in vitro diagnostics products, samples are often collected for testing in a centralized manner thus increase the speed at which the enrollment and testing is performed. The proper handling of sample storage, and the proper use of reagents and the associated instrument are also very important for the test results.
Advantages of Tigermed
After completing the wholly-owned acquisition of Jyton Consulting in 2017, Tigermed has become the most competitive medical device CRO in China. Tigermed has established a professional medical device team which has a strong background in registration and clinical trials, and has access to a wide range of expert resources. Our medical device experts can provide you with full lifecycle services for both medical devices and in vitro diagnostics including market survey, marketing strategy development, product validation and finalization, GMP system counseling, clinical trial/clinical evaluation, registration application, post marketing support, etc.. We have established long-term and stable cooperation with over 1,400 manufacturers from more than 30 countries.
For registration and testing services for medical devices and in vitro diagnostic reagents, Tigermed currently employs over 50 people specialized in regulatory affairs. As a team, they are familiar with all applicable regulations, policies, and registration procedures for domestic and import devices and in vitro diagnostic reagents. Many renowned international medical device companies have become our long term partners. By the end of the first half of 2019, Tigermed has handled registration for over 5,000 domestic and import medical device products. Additionally, we have arranged Tigermed engineers in major testing labs to effectively communicate with the testing labs and subsequently shorten testing time.
An independent team for medical device and another independent team for IVD are also a feature of Tigermed solution. To ensure compliance during clinical trials and all the applicable requirements of medical device or IVD, Tigermed has set up an in house Quality Management System with complete and standardized SOPs. Years of clinical trial experience has led to a mature and effective operation system. During the implementation process, the division of teamwork is clear and the team is efficient. Strong team support ensures that projects are carried out and completed according to the intended goals and milestones. Also, when problems are encountered, timely and effective support is obtained from all parties to mitigate the risk. Through standardized project execution and management, effective coordination of functional departments, experts, clinical study sites, laboratory institutions, and good cost control, Tigermed brings fast, high-quality, convenient, and low-risk services to its clients.
Tigermed’s medical professionals can also support you with medical device product clinical evaluation. We will search for clinical literatures by using dedicated international literature library, combine evaluations of professionals in various fields, and analyze data comprehensively and systematically, to provide you with feasibility assessments and high-quality clinical evaluation reports.
Lastly, Tigermed has an independent medical device biometrics team, which is the largest among all CROs in China that specialize in medical device trials. They support our sponsors from China, the US, and the EU in protocol design, data management, statistical analysis, clinical evaluation reports and other related services to facilitate their medical device or IVD clinical development.
The medical device team is managed by 8 project directors and over 20 project managers that have an average working experience of 5 years. Together, they have a combined track record of over 300 medical device clinical trials.
In addition to conventional services, Tigermed also offers solutions in areas like:
Global Certification and Business Expansion
We support our Chinese clients to enter the global market by assisting them in the EU CE and FDA 510k certification and thus expanding their market opportunities. For clients abroad, we act as a gateway to China by supporting their product registration.
Market Survey and Consultation
We also provide various types of medical device market surveys and consultation in China to assist our client in developing their product registration strategy.
Our clinical trial experience includes but is not limited to the following medical device therapeutic areas:
- Dermatology/ Plastic Surgery
- Infectious Diseases
- Clinical test
- Hepatological Surgery