Central laboratory

As a trial sponsor, are you seeking to obtain FULL OVERVIEW OF THE GENERATION OF YOUR BIOCOLLECTIONS during the course of your clinical trials and to maintain the integrity of your samples? Are you looking to offer INVESTIGATOR SITES STRAIGHTFORWARD OPERATIONAL SOLUTIONS, adapted to their needs and constraints?

Via a rigorous process, Cell&Co is by your side through each successive stage of your phase I, II and III multicenter clinical trials. We design comprehensive bespoke services for precision biomedical research in the interests of patients. In addition to storing your biocollections in ultra-secure, GMP standard infrastructures, we provide centralized administration of all your logistics flows, including those not routed to Cell&Co. We design your sample collection kits in order to guarantee straightforward and efficient sampling by your trial partners. Lastly, our partner laboratory prepares and tests your samples using validated processes, to ensure impeccable control over analytical variables and guarantee robust results.

Cell&Co therefore manages the processing, storage and logistics requirements of your clinical biocollections, both in Europe and internationally. Our personnel closely collaborate with service providers (trial centers, carriers, central laboratories and monitoring CRO) to ensure that their activities are fully aligned with the demands of your clinical trials.

Our process

Design

- Design of logistical and traceability solutions

- Selection of materials suitable for the study

- Identification of subcontractors

Initiation

- Regulatory submissions

- Training for investigator sites

- Design of documentation

- Provision of laboratory equipment/materials

Management

- Sample and kit logistics

- Entry of data of sample-tracking

Receipt / Sample preparation

Sample Analysis / Reorganization / Retrieval / Disposal

Continous updating of the Biotracker^TM database

Closeout

- Study report and review of indicators

Sample Analysis / Reorganization / Retrieval / Disposal

Continous updating of the Biotracker^TM database

Biocollection follow-up

- Handling of sample managment requests

Sample Analysis / Reorganization / Retrieval / Disposal

Continous updating of the Biotracker^TM database

Our coordination commitments

Investigators sites

– Training and support for teams
– Clear, intuitive collection procedures
– Innovative sample identification systems

Monitoring CRO

– Combined reporting of monitoring data and biobanking data
– Strengthen communication with investigator sites

Carriers

– Coordination of logistics providers and monitoring of contractual commitments
– Setup and monitoring of transport-related indicators

Bioanalysis laboratories

– Coordination of analytical operations
– Centralization of results and integration into Biotracker^TM

Sponsor

Customized, real-time reporting:
– Study progress statistics
– Status of samples and sample-related data
– Information on dispatches and receipts

Benefits to you

Have access to high value-added technical solutions

Obtain superior performance and greater peace of mind regarding the management of your clinical trials

Boost the engagement of investigator sites and simplify their work through our direct participation

Our expertise

Sample collection kits

Production and distribution of bespoke kits designed with medical teams

Design of related documentation (laboratory manual, sample collection form, kit instructions, color-coded label sheets, etc.)

Traceability of the link between kit and biosamples

Logistics

Administration and tracking of all movements, including those not routed to Cell&Co and complex flows (e.g. patients’ homes)

Management of regulatory and customs formalities

Coordination of parties involved in the cold chain: sender, recipient, and carrier

Secure storage

Inspection of samples (identification, quality, volume, color, etc.) and data entry in GMP conditions

Cold chain optimized, based on our biological expertise, our various in-house tests, and our experience

24/7 surveillance via on-call personnel and secure infrastructure

Sample preparation and analysis

Automated sample preparation process prior to storage: aliquoting, DNA/RNA extraction, PBMC isolation, paraffin blocks/slides

Technology centers equipped with state-of-the-art instruments for your routine analysis requirements (650 possible parameters) or specialized assays: biomarker or drug assays, cell analyses, molecular genetics, etc.

IT solution

Remote administration of your biocollections via our Biotracker™ software (FDA 21 CFR Part 11 compliant) providing a customizable user interface

Traceability within our Biotracker™ LIMS of all stages of the life cycle of your samples, including bespoke reports

Real-time access to sample lists and related data: status, clinical data, storage site, quality results, etc.

Project management

Dedicated contact person from the pre-sales phase to project close-out

Bespoke reports designed at the pre-project phase based on your requirements and on exploitation of the data from our Biotracker™ LIMS and our ERP

Project close-out to identify the strengths of the project management and key areas for continuous improvement, followed by deployment of the associated implementation plan

Testimonial

The search for biomarkers is a growth area in clinical trials and generates large volumes of samples. As we were looking to safeguard and centralize these resources within a high-quality biobank, we conducted a full audit of Cell&Co before selecting this partner. Cell&Co arranged for central collection of all our samples from over 70 French hospitals. Our collaboration has continued by extending to sample collection and logistics for major multicentre clinical studies. We particularly appreciate the team’s responsiveness and professionalism.

IFCT (French Cooperative Thoracic Intergroup)