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Project management

Based on best-in-class industry standards, the clinical operations department has traditionally been the backbone of our services. Project Leaders possess an advanced academic education (MS/PhD/PharmD), and an extensive training in team management, project management, and digital tools. They receive continuous professional development, bolstered by mentoring and knowledge sharing.

Depending on Sponsors’ different needs, we offer an adaptive Project Management model, varying from minimal, where the Sponsor manages the study closely, to fully outsourced, where ClinSearch manages all study activities from start to finish. The Project Management model is agreed upon at the beginning of each study and can be changed at any time at the discretion of the Sponsor and in consideration of the progress of the study. Our initial recommendation for a Project Management model is derived from benchmarking the study against similar studies.

We send reports to the Sponsor on a weekly basis prior to patient enrollment and on a bi-weekly basis after the start of enrolment, provided that enrolment is progressing according to plan. To ensure service continuity, a Project Leader and a Deputy Project Leader are paired up for each project. The department is led by one of our longest serving staff members, Cecile Train.

Our solutions

PREPARATION OF STUDY DOCUMENTS
TEAM TRAINING
SITE & RESOURCE MANAGEMENT
CEC & CORE LAB COMMITTEE MANAGEMENT
ISSUE RESOLUTION
REPORTING TO SPONSOR
BUDGET MANAGEMENT
TMF MANAGEMENT

Resources

Senior clinical operations director
Global deputy operations director
Project leaders
Deputy project leaders

Activities

Project management
Budget management
CRA management
Reporting

Regulatory submissions

With two experts exclusively dedicated to regulatory processes, we are making more than 50 study submission per year across Europe, with a success rate of 99% over the last 5 years. Prior to commencement, our experts can provide input regarding the regulatory practices in each country or support Sponsors with country or site feasibility. Our goal is to provide a realistic overview of approval times and potential delays.

The regulatory process is managed by our Regulatory Affairs Director, in collaboration with the International CRAs or Country Experts, who validates the accuracy of study document translations and adapts them to local regulations. As part of the submission process, we provide follow-up contact and a round of questions.

The department can also undertake all relevant data privacy protection checks as per GDPR, or conduct an audit when necessary. So far, a Privacy Impact Assessment (PIA) is required only in France, but other European countries are likely to follow suit.

Our solutions

REGULATORY MAPPING
REGULATORY INPUT INTO PROTOCOL
REGULATORY ADAPTATION OF STUDY DOCUMENTS
PREPARATION OF DOSSIERS FOR ALL OF EUROPE
SUBMISSION TO ECS AND CAS
NEGOTIATIONS WITH THE AUTHORITIES
PIA & DATA PROTECTION ACTIVITIES
SUBMISSION OF AMENDMENTS
SAFETY REPORTS
CLOSE-OUT NOTIFICATIONS

Resources

Regulatory affairs director
Regulatory affairs project manager
DPO

Activities

Regulatory feasibility
Submissions of core dossiers and amendments to CAs and ECs
Communication with CAs and ECs
Data protection evaluations
Privacy Impact Assessments

Monitoring activities

Our trained multilingual monitors are rigorously selected and trained to meet the objectives of excellent monitoring and data collection service.

At ClinSearch, monitoring is always managed by permanent staff members with appropriate CRA qualifications or training, and fluency in the languages of your selected site locations. Our team includes experts fluent in French, English, German, Dutch, Spanish, Italian, Danish, Swedish, Arabic, Indian, Polish, Romanian and Bulgarian.

CRAs are carefully chosen based on your study requirements and are meticulously trained on the specificities of your protocol and product.

Our solutions

INITIATION VISITS
ROUTINE MONITORING VISITS- REMOTE AND ON-SITE
CLOSE-OUT VISITS
DATA COLLECTION
SITE SUPPORT WITH PATIENT RECRUITMENT

Resources

CRAs
International CRAs
Data collection officers

Activities

Site Feasibility and selection
Monitoring Visits
Data collection