Clinical Operations

Start up and small to medium sized companies have the challenge to meet EU2017/745 MDR & EN ISO 14155 compliance while not having full clinical expertise in house. TRIQ  understands the needs of smaller companies and we can be your partner to achieve your goals, faster and with less complications. Short communication lines will make the processes transparent for full support of your Clinical Investigation Studies from feasibility to completion. In general, we assign a single study manager as your main point of contact throughout the Clinical Investigation Study.

Study Management

From Feasibility  to conducting a Clinical Trial with an Investigational Device or a Post Market Clinical Follow-Up (PMCF) Trial, TRIQ is your partner to provide comprehensive support. The TRIQ team is highly skilled and experienced in project management, site management including monitoring, field clinical support & proctoring, clinical trial supply management,  regulatory, safety management and recruitment.  Our team is multi-lingual and  trained according to EU 2017/745 MDR, EN ISO 14155 and all other applicable regulations and laws within the EU.

Clinical Site Visits and Monitoring

We help the sponsors with clinical site selection, assessment & qualification. TRIQ conducts site initiation visits and trains the clinical investigation site staff to the complete Clinical Investigation Study.

Monitoring is performed by very experienced and local CRAs who also have a technical understanding of Medical Devices. The process of clinical monitoring has changed significantly over recent years with the current EN ISO 14155 regulation. Today, CRAs must understand their new role, supporting clinical investigation sites and sponsors to reach robust clinical data and to ensure the protection of subject rights. We believe in the transition of CRA’s to consultants, who enhance the value of each Clinical Investigation Study, as the path forward to improve the monitoring performance. We help sponsors to find the right balance of clinical on-site monitoring and remote monitoring activities to suit your particular Clinical Investigation Study. The TRIQ CRA team receives full back-up support in complex technical issues by our in-house engineers.

Study Documents

TRIQ can help you with the design, development and review of study documents for the Clinical Investigation Study in compliance with the EN ISO 14155 regulation.

• Clinical Investigation Plan
• Investigator Brochure
• Informed Consent Form
• Other applicable clinical investigation documents

Study Document Management (TMF/ISF)

The management of study documentation is essential to the success of a Clinical Investigation Study providing means to evaluate Clinical Investigational Study conduct, data integrity and compliance with all applicable regulations. Over the years, the extent of such documentation grew exponentially and requires even more expertise to develop and manage the Trial Master File (TMF) and the Investigator Site File (ISF) than in the past.