Clinical Trial Services

PProject Management Team
Clinical Trial

Targos has screened more than 50.000 patients as part of its clinical trial services. The company has acted as a GCP compliant patho-diagnostic reference center for more than 100 companion diagnostic trials for international pharmaceutical and biotech companies. Our projects and facilities have been regularly audited by international customers and the US Food and Drug Administration (FDA).

For a publication list of clinical trials
supported by Targos, click here



Project Management

The project managers are the primary contact for our clients, working closely to ensure the accuracy and the timeliness of the project. They all have a strong research background with a PhD in biological sciences, supported by a team of secretaries. They manage workflow at Targos; between Targos and the client or other parties, and supervise the project performance and communication with the client and investigational sites.


Data Management

  • Planning of data collection
  • Customization of database structure
  • Customization of reports
  • Data import and export to customer sites
  • Data archiving

Logistics

Our experts meet the unique logistic requirements of our customers for each study. This includes design and distribution of shipment kits for sample collection and transportation of biological samples in full compliance with the appropriate regulations. Sample transport needs range from FFPE specimens transported at an ambient temperature to nucleic acids or other temperature-sensitive material shipped on dry ice. Specimen shipments are received and sent via commercial courier Monday through Friday 8 a.m. to 4 p.m. Local and international sample transportation is through major courier companies.


Quality Management

Patient care and safety are our guiding principles in quality management. 

Targos quality management programme is designed to produce the highest quality of professional and ethical service to our customers in accordance with international accreditation standards such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), DIN EN ISO 9001 / DIN EN ISO/IEC 17025/17020  as well as legal requirements and instructions of professional associations.

Analytical procedures are validated according to ICH Q2(R1) guidelines and the FDA guidance for “Bioanalytical Method Validation”. Computerized systems are validated according to the requirements of EU GMP guideline 2003/94/EC and FDA guidelines 21 CFR Part 11.

Our quality management programme is used in biomarker clinical trials for successful application and execution of standardized procedures for all involved process steps, which include e.g., the performance of regular internal audits of processes and projects, the participation in external proficiency testing programs (e.g., CAP, NordiQC, QUIP), CAPA-handling, extensive staff training, supplier qualification, failure & complaint management, consultancy, review of project plans, inspection of documents, SOP and many other processes (see illustration).

Our team of Auditors and QA Managers has managed more than 50 customer audits and inspections by the authorities, such as the FDA.

Explanation of acronyms

CAP: The College of American Pathologists
NordiQC: Nordic immunohistochemical Quality Control.
CAPA: Corrective and Preventive Action
QUIP (A German acronym for Qualitätssicherungs-Initiative der Deutschen Gesellschaft für Pathologie und des Berufsverbandes Deutscher Pathologen zur diagnostischen Immunhistochemie und Molekularpathologie)