Project management

Resources

Senior Clinical Operations Director
Global Deputy Operations Director
Project Leaders
Deputy Project Leaders

Description

Modelled on best-in-class industry standards, the clinical operations department has traditionally been the backbone of the services we offer. Project Leaders have scientific background, normally educated to a MS/PharmD level, and have a minimum of 3 years of project management experience.
In reflection of Sponsors’ different needs, we have an adaptive Project Management model, varying from minimal—when the Sponsor manages the study closely, to fully outsourced, where ClinSearch is managing all study activities from start to finish. The Project Management model is agreed at the beginning of each study and can be changed at any time at the discretion of the Sponsor and depending on the progress of the study. ClinSearch’s initial recommendation for a Project Management model is derived from benchmarking the study against similar studies we have managed.
Reporting to Sponsor is normally done on a weekly basis until patient enrollment starts and bi-weekly after the start of enrolment, provided that enrolment is progressing according to plan.
A pair of Project Leader and Deputy Project Leader is paired up for each project to ensure service continuity. 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

Standards & Guidelines

EMA's Guideline on Data Monitoring Committees
WHO's Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards
FDA's Establishment and Operation of Clinical Trial Data Monitoring Committees- Guidance for Clinical Trial Sponsors
FDA's Clinical Trial Imaging Endpoint Process Standards Guidance for Industry

Day-to-day activity

Project management
Budget management
CRA management
Reporting

Regulatory submissions

Resources

Regulatory Affairs Director
Regulatory Affairs Project Manager
DPO

Description

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. Before the beginning of studies, in case of doubt about the countries or sites of study conduct, our experts can provide input regarding the regulatory practices in each country or support Sponsors with country or site feasibility. The goal is to provide a realistic overview of times to approval and any delays that might be encountered.
The regulatory process is always managed by our Regulatory Affairs Director, who works in collaboration with the relevant International CRAs or Country Experts to validate the accuracy of study document translations and adapt them to local regulations. Follow-up and one round of questions are always included as a part of the submission process.
The department can also undertake all relevant data privacy protection checks as per GDPR, or conduct an audit when necessary. So far, a PIA (Privacy Impact Assessment) is required only in France, but other European countries are likely to follow suit.

Our solutions

Regulatory mapping - Selection of best countries and sites
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

Standards & Guidelines

EN ISO 14155:2011
ISO 9001:2015

Day-to-day activity

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

Monitoring

Resources

CRAs
International CRAs
Data collection officers

Description

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. Languages that are represented on the team include French, English, German, Dutch, Spanish, Italian, Danish, Swedish, Arabic, Indian, Polish, Romanian and Bulgarian.
CRAs are selected according to your study requirements and trained on the specificities of your protocol and product.

ClinSearch does not work with freelancers in order to ensure uniformity and quality of service.

Our solutions

Initiation Visits
Routine Monitoring Visits- Remote and On-Site
Close-Out Visits
Data Collection
Site support with patient recruitment

Standards & Guidelines

ICH E6 Good Clinical Practices
Good Epidemiological Practices

Day-to-day activity

Site Feasibility and selection
Monitoring Visits
Data collection