Clinical Studies – Service & Support
Types of support provided
- Study Management
- Clinical Protocol Preparation
- CRF Development
- Clinical Monitoring
- Adverse Events management
- Data Management
- Statistical Data Analysis
- Final Reports Preparation
From Study Design and Advice to File Submission
Any investigator considering to start a trial, is invited to drop us a note. We will be happy to discuss the plans and provide an initial advice.
Training, Mentoring and Monitoring
IMS team will provides, Project Management, assist Clinical Investigators with regular visits by Hospital Data Managers, Clinical Monitors and Medical Advisors. Our tailored training programmes are compliant with regulatory requirements. We offer cost-effective on-line courses with no need for on-site participation as well as in-house courses, workshops and practical simulations.
In agreement with our style of intervention, we always develop strong interaction with our partners, It is then obvious to tighten relationships between monitors, data managers and investigators with meetings, seminars and updates during the development of the trial.
Constant interaction is a safeguard for the respect of timelines or requirements, allows better and smoother data reporting and obviously facilitates networking and information sharing.
IMS will develop the most appropriate eCRF that will be created in partnership with the ICT team and directly provided for use to customers for test through a secure client-server architecture.
The Data Management team interacts with the Clinical IT team to develop the electronic data capture (EDC) system and ensure Computer System Validation.
Statistical Data Analysis and Management
Strict control of data collected during the complete lifespan of the project if of paramount importance. IMS provides a wide array of statistical tools through its biostatistical team that will be supporting the project along its lifespan (e.g, from its very beginning with sample size estimation to data for regulatory and publication submissions).
Final Reports Preparation
A team of senior medical writers is responsible for the preparation of comprehensive clinical study documentation fully compliant with ICH and GCP guidelines. Besides its seniority, the medical writing team remains under strict clinical and statistical supervision, in order to deliver the best possible quality. Our medical writing team is skilled in the production of any tool needed in a Clinical Study as: Study Protocols, Investigator Brochures, Patient Information Leaflets and Informed Consents, Investigator’s Operating Procedures, Regulatory dossiers, Interim and Final Reports, Medical Publications