Itec services

Clinical study management

Study siting and monitoring:

ITEC SERVICES set up from its start in 1984 a department to manage and coordinate clinical trials. We can draw on the experience of Project Leaders, CRAs, Clinical Trial Managers and external experts, at any moment, to solve problems concerning:

- Scientific aspects
- Regulations
- Pharmacovigilance

The range of skills within our staff and associates, our competence in clinical studies, and our investigator network, enable us to work with specialised and frequently complex methodologies.

 

Proof of our commitment to quality is that ITEC SERVICES was amongst the first French CROs to be awarded ISO certificate 9001 for the entirety of its activities.

Our expertise in clinical research, and the added-value of our management systems, transform our clients’ projects into effective dossiers and sound bases for development strategies.

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Our Project Leaders:

ITEC SERVICES Project Leaders are intermediaries to Sponsors. They identify and deal with all delays touching their projects. Their primary aim is to satisfy the Sponsor. Our Project Leaders can also set up on-line project management so that the Sponsor can follow a clinical trial’s progress, at any time.

ITEC SERVICES Project Leaders organise projects, as follows:

Administrative preliminaries:

• Initial steps (Investigator brochure, Consent, CRFs…)
• Negotiate with CCP, CNO, AFSSAPS, hospital managers, and hospital pharmacists.

Pre-study enquiries and contacts:

• Evaluate centres for their recruitment potential
• Evaluate regulatory compliance and responsible personnel
• Establish telephone contact before initial visit
• Organise investigator/Sponsor meetings

Project team management:

• Train project teams on study pathologies, protocol, CRF completion, logistics
• Arrange project meetings with Sponsor
• Plan quality audit, corrective actions, prevention
• Study treatment control (ordering, stocking, storage conditions, dispensing, return, destruction…)
• Schedule monitoring visits
• Plan communications with investigator (mailings, newsletters)
• Manage fees (BAP for each invoice with follow-up)
• Present progress reports

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Our CRAs:

Human resources at ITEC SERVICES are critical to our clinical research success. Attributes possessed by our CRAs (scientific rigour, flexibility, reactivity, empathy and relational skills) are indispensible to deal with investigators and to convey your image.
ITEC SERVICES employs professional CRAs dedicated wholly to their work and your clinical studies.

ITEC SERVICES CRAs are highly experienced in :

• Current clinical trial regulations
• Monitoring procedures
• Case report form completion
• Study logistics pertinent to site visits
• Trial quality criteria and data validity
• Relevant pathology
• Protocol requirements…

These claims are justified by regular assessments to improve competence. Training is pivotal to the quality system operating at ITEC SERVICES. Our CRAs are committed to protect your image at all times and ensure the confidentiality of your data.

CRA monitoring procedures:

Initial investigator meeting/visit:

• Relate to investigators and train them on protocol and data collection…
• Distribute site supplies and control stock according to procedures established at the first visit.

Follow-up/recovery of valid data:

• Follow-up study as stated in by the protocol
• Efficiency
• Check BPC payment
• Check signed consent
• Check conformity to selection criteria
• Check source data
• Check pathology and associated treatments
• Check for protocol deviations
• Follow-up of EIG
• UT accountability
• Write monitoring report and resolution of any problems

- Final visit:

• File study documents
• Remind investigators of obligation to archive source data
• Arrange return of trial supplies and unused treatments

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