Client Services

Clinical Trials Cient Services

Processing Offer
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Project Management

Dedicated project managers with scientific background

Experienced in 600 trials our project management team is your primary contact for proposals, well controlled processes, biomarker implementation, work flow and contracts. The large team handles set-up, performance monitoring and reporting as well as the communication with all involved stake-holders avoiding imformation gaps.

  • One primary contact.
  • PhD level scientist project managers.
  • Complete project life-cycle management.
  • Sample managment & communication experts.
CAPA&CLIA

Quality Management

15 years experience lead to consulting of customers

The Targos Quality Management Team has 15 years experience in setting up the Targos Quality System and managing > 500 trials under GCP and US-CAP CLIA conditions including CDx approval trials. Close to 100 Audits by the FDA and customers were hosted with great success. With EU IVDR regulation coming up in 2022 customers will need consultation for upcoming projects in the field of regulatory approval.

  • Management of ISO and CAP-CLIA environment.
  • Experience with FDA and EMA requirements.
  • Preparation of IVDR requiremnts.
DataManagement

Data Management

Multiple solutions for data capture & reporting in complex trials

The data management team supports the Targos processes with data capture and reporting solutions for clinical trials from translational research to approval trials. Well managed processes enable fast turnaround times for patients screening studies.

  • FDA approved LIM System for sample and data management.
  • Fast and flexible implementation of new work flows
  • Data reporting by encrypted mail, share server or web portal.
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Assay Development

Facilitating development from RUO to IVD CDx

Scientists, pathologists and technicians support your biomarker development needs from reagent selection until IVD approval in a GCP US-CAP CLIA environment. Tissue samples for validation can be provided from own repository or from commercial tissue banks. Targos has most automated platforms available for IHC, IF and molecular pathology assays, such as qRT-PCR, mutation analysis.

  • Validation protocols for tissue and blood assays
  • App development for digital pathology
  • Validation times as low as 3 months
Logistics

Sample Logistics

Controlled sample handling & shipment for all study types

A safe and controlled sample flow between clinical sites, Targos and third party labs is important for the success of any study. Targos has extensive experience with the organization of global study logistics, including shipment kit construction, lab manuals and instructions.

  • Global inbound and outbound shipments with trusted couriers.
  • Tailored shipment kits.
  • Sample hub services for complex trials.
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Archiving and Cryo-archiving

Secure storage from RT to -70°C up to 15 years

At Targos, we are committed to preserving and maintaining the quality and integrity of your sample's by adhering to the standards mandated by Good Laboratory Practice (GLP) regulations. The facility has dedicated space protected by several layers of security, such as controlled access via both card key and traditional lock and key, a 24-hour security monitoring system, temperature monitoring, fire wall, and fire alarm system.

  • Physical & Digital storage of stained slides.
  • Secure Source data storage.
  • Biorepository for Tissues and Nucleic Acids.
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Biomarker Training

Targos Advance training & Consulting.

In collaboration with pharmaceutical companies and thought leaders, the Targos Advance Team provides expert training for pathologists and technicians.

  • Long term experience in organization expert meetings on site and at different venues globally
  • Standardization and biomarker testing related to IHC and ISH
  • Global pathology network
  • Since 2010 >3500 pathologists trained world wide