Clinical Operations

At ExperTrials Consulting, our commitment is to be focused on three primary objectives:

Qualifying the right physicians for the trial,

Initial and ongoing training and support of Investigator site staff,

Ensuring the study is met with the highest standard of patient safety and data integrity.

 

ExperTrials Consulting provides comprehensive study site monitoring services. We support the entire study life cycle from investigator selection through to database closure.

 

Country and site Feasibility/ Pre-study visits Training of site staff Initiation visits Collection of critical documents Remote and on-site monitoring Handling of therapeutic units and medical devices accountability Handling of SAE Close-out visits Filing of documents in TMF Query resolution		Participation in the Investigators selection strategy Final selection of centre Regulatory documents collection 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
	Site staff and pharmacist training (GCP ICH, FDA regulation, sponsor’s SOPs, protocol) Resolving all remaining queries in a timely manner Filing on a regular basis study documents for the TMF

Consultants have effectively monitored studies across all phases of product development and  consistently ensure the collection of high-quality clinical data on-time.

Experienced Professionals. Each consultant has extensive experience in Clinical Research with diverse clinical backgrounds. Please download our CVs for more details.

Customized Teams. Each consultant becomes a part of your project team, which is structured to meet your individual needs with  particular focus on therapeutic expertise and geographic scope. This customized approach produces an experienced, detail-oriented team with minimal start-up time and which consistently provides superior monitoring services through the duration of the project.

Clinical Study Agreements. We do more than just identify your investigators. We carefully assess each potential investigator based on the specific requirements of your study. We negotiate clinical study agreements using a mutually acceptable clinical study agreement template. We also work with you to draft alternative language and budget parameters in anticipation of negotiation based on our extensive experience. By anticipating requests for changes and creating alternatives in advance, we can rapidly negotiate your clinical study agreements, expediting your trial initiation, and work throughout the trial to make any necessary changes.

Investigator Meeting Coordination. We have extensive knowledge and experience to support all levels of Investigator Meetings from the Phase II studies to the Phase IV studies. We will support you in organizing a successful Investigator Meeting in compliance with your budget, goals and objectives, and following industry compliance guidelines by setting-up electronic registrations, meeting place, transportation, hotel room booking.

 

Site activation. In addition to the regulatory submission and study site agreement processes, we coordinate the collection, review and tracking of essential documents and assist the sites to achieve their activation dates according to the project deadlines.

 

An additional service at Expertrials consulting includes the design of Informed Consent Form in accordance with

ICH/GCP and local EC requirements, depending on your expectations.