Clinical Investigation 2018-01-05T16:55:05+08:00

Clinical investigation services for medical devices and IVD devices in Southeast Asia

Andaman Medical offers a “One Stop Approach” for clinical investigation of medical devices in Southeast Asia

The clinical team at Andaman Medical will work closely with you to ensure that clinical research for your medical device or IVD products meets international standards and adheres to the local ethical committee requirements in Southeast Asia.
Andaman Medical offers a unique “one-stop service’’ approach, providing a full range of clinical evaluation services to ensure that your medical devices or IVD devices adhere to International Organization of Standardization (ISO) 14155: “Clinical Investigation of Medical Devices for Human Subject – Good Clinical Practice (GCP)” and local regulatory requirements.
Our clinical team work closely with our clients to ensure that clinical investigation is designed in accordance with international standards and local ethical committee requirements. Andaman Medical is committed to conducting clinical investigation with the highest standard of integrity. We assist you in monitoring and auditing clinical evaluation processes to ensure clinical investigation of the highest calibre.

“Optimize your chances of success right from the first submission – leave your clinical evaluation in the hands of our GCP-certified clinical consultants.”

Cost Effective & Timely

We provide high calibre clinical evaluation services to ensure that medical device and IVD device clinical investigations are conducted in a cost-efficient and time-effective manner and delivers high quality results that are compliant with ISO 14155-GCP standards and local regulatory requirements.

Our Clinical Trial Services

  • Clinical trial design
  • Project management
  • Clinical monitoring
  • Data management
  • Clinical report writing
  • Safety surveillance
  • Reimbursement strategy
  • Post approval / post-market management
  • Quality assurance management / compliance

Clinical Investigations – FAQ

Import and supply of unregistered medical devices into some ASEAN countries for use in clinical trials requires the approval of the relevant authority. Application for the approval of the import and supply of unregistered medical devices or IVD devices for both investigational and non-investigational purposes in a clinical trial is to be made in accordance with the local regulations. Most ASEAN countries have not regulated clinical trials yet, but it is recommended for sponsors and investigators to comply with the Good Clinical Practice (GCP) guidelines to ensure the protection of trial participants’ rights and interests.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. It is of the utmost importance that this standard is upheld at all times when research involving human subjects is conducted. In doing so, the rights, safety and well-being of the study subjects are safeguarded in keeping with the principles that have their origin in the Declaration of Helsinki. GCP are implemented for either pharmaceutical drugs or medical devices.

EN ISO 14155-1: Clinical Investigation of Medical Devices for Human Subjects – General Requirements is a harmonized standard that details the general requirements for the conduct of clinical evaluations.

EN ISO 14155-2: Clinical Investigation of Medical Devices for Human Subjects – Clinical Investigation Plancontains detailed information about the procedure and contents of a clinical investigation plan. Clinical investigations must take into account scientific principles underlying the collection of clinical data along with accepted ethical standards surrounding the use of human subjects. The clinical investigation objectives and design should be documented in a clinical investigation plan.