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Welcome to Expertrials Consulting

Expertrials consulting is a French Limited Company founded by two Clinical Research consultants and created on 2nd of May 2011. Our commitment is to provide our clients with the expertise required to conduct their clinical trials in France.

ExperTrials Consulting is a fully integrated services provider for :

Human and veterinary medicinal products,
Medical devices,
Food supplements and cosmetics,

Extensive collaboration with colleagues coupled with ongoing communication with clients ensures the smooth integration of services.

Read more about our services and find out how we keep our clients' clinical research efficient, safe and cost-effective

CRA Mission

  • Country and site Feasibility / Pre-study visits Demo Image
  • Training of site staff
  • Initiation visits
  • Collection of critical documents
  • Remote and on-site monitoring
  • Handling of therapeutic units and drug accountability
  • Handling of SAE
  • Close-out visits
  • Filing of documents in TMF

Project Management

  • Participation in the Investigators selection strategy
  • Final selection of sites Demo Image
  • Liaising directly with NCI for synopsis approval, ICF and IM preparation
  • Setting-up of Investigator’s meeting
  • Handling financial agreements with Hospitals, Investigators, Association or tripartite.
  • Review of monitoring report
  • Coordination between CRAs and sponsor
In accordance with your timelines, budget and the assessed risks

QA and site audit preparation

  • Site staff and pharmacist training (GCP ICH, FDA regulation, sponsor’s SOPs, protocol)

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  • Resolving all remaining queries in a timely manner
  • Filing on a regular basis study documents for the TMF
  • SOPs development and implementation

Regulatory Affairs

  • Initial submission (Interventional/ observational studies) to EC and CA
  • 1st patient notification (For France)

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  • Substantial/non substantial amendments
  • End of trial notification
  • CSR synopsis notification (1 year after the LPLV)
  • Payment of submission fees to CAs

On-site support

  • Support investigators on siteDemo Image
  • Pre-screening of patients
  • eCRF filling
  • Support management and traceability of clinical supplies (in case of global dispensation)
  • CRA Mission

    CRA Mission

  • Project Management

    Project Management

  • QA and site audit preparation

    QA and site audit preparation

  • Regulatory Affairs

    Regulatory Affairs

  • On-site support

    On-site support