Clinical Research is understood to mean any study carried out on human beings in health. It is a very supervised, follows a precise study protocol, and is only carried out under certain conditions.
Clinical Research includes all the clinical trials carried out in humans, which allow:
- Either to test new drugs (or medical devices) with a view to a Marketing Authorization (MA): this is Industrial Clinical Research,
- Either to compare existing care strategies or existing diagnostic techniques, to optimize or harmonize them: this is Institutional Clinical Research.
Clinical Research Monitoring aims to bring new therapeutic perspectives or provide a benefit compared to the current state of knowledge for the various pathologies from which patients suffer.
What is a Clinical Trial?
Clinical trials aim to evaluate new treatments (or medical devices). Before offering them to all affected patients, it must be ensured that they are effective and well-tolerated.
Medical Monitoring Clinical Trials or therapeutic trials must in particular assess:
- New drugs or combinations of drugs (against the disease or its side effects);
- New ways of administering them (by tablets rather than by injection, for example);
- New treatment techniques (a new type of surgery or different management, for example) or diagnostic (new biological test, for example).
What is a Trial Management System?
Clinical Trials Management System is used to treat the data of a clinical study systematically and efficiently, whether it is to store, consult or update it. These systems ensure the integrity and traceability of the data and its security, an essential factor in the field of clinical trials since we work with patient data with confidential information.
A clinical data management system consists of an electronic data collection notebook (CRDe) and an associated database, where the data registered in the CRDe are stored. As detailed in a previous article, there is an excellent variety of CRDes, and there are also many types of databases. Still, some of the most used are Access, Oracle, Dbase, SQL Server, File Maker or MySQL.
When choosing an appropriate tool for an investigation, it is critical to determine the variety of data that will be used and how complex it is, but also the number of data that will be collected, the number of researchers that will make use of it, the ease offered by the tool to be able to import and export the data to other programs and platforms.
Why Choose Clinical Trial Management Services?
It offers:
- Supervision and management of local and international trials.
- Establishment and oversight of providers.
- Clinical development program consulting.
- Study design and protocol writing.
- Tailored selection and maintenance programs.
- Feasibility studies and detailed risk assessment plans for the country assessment, including regulatory framework, disease prevalence, access to patients, centre capacities.
- Site selection and clinical qualification.
- Online access to enrollment status and prognosis and other key performance indicators through a clinical trial management system (CTMS).
- Access to therapeutic specialists providing Clinical Trial Monitoring Services.
- Multidisciplinary teams that offer advantages in efficiency and quality.
- Worldwide use of a single clinical trial management system.
- Seamless collaboration between all test management offices.