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Why Us?
The key elements of our approach are:
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Permanent employment of highly qualified individuals to allow stable teams to be formed.
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A high degree of standardization of activities prone to interindividual variation, using a written formalized documentation
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Intensive in-house SOP and project-specific training, according to individual training plans, which are annually revised.
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Regular external training by leading providers of clinical research expertise
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SOPs according to ICH-GCP, which take into consideration the needs of successful
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Clinical research in compliance to GCP.
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Our CRAs are employed, or long-term contracted freelancers, who are subjected to the quality assurance procedures.
Field-based activities are carried out by CRAs with PhD level scientific background. Depending on the experience level of the monitor, the CRA supervisor performs co-monitoring visits in each phase of the trial at least twice a year.
Medium-size CRO
R&D is a medium-size CRO (Contract Research Organization) that’s just the right size for most of your needs. Not too big and bureaucratic, but rather agile and flexible. Not too small, but with the demonstrated depth of experience and knowledge to bring real value to your project. We hand-pick each and every one of our staff of research professionals. They’re smart and focused. They zealously live and breathe their projects, providing meticulous attention to the details
Executions are crisp, timely, and accurate. You receive truly personal service - and our senior management gives you their attention. If this sounds appealing to you, please contact us for more information. contact us para mayor información.
A survey on CRO quality, conducted in 2001 by CenterWatch, found out that it is the medium sized CROs that are now deemed more responsive, accessible and much less bureaucratic. The advantages of being a medium sized organization are well known:
- Flexibility
- Quality of staff
- Close communications
- Efficient and non-bureaucratic internal processes
- Quick adaptation to changes
- Low cost
How do we ensure quality in all our monitoring activities?
General Training:
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Continuous CRA co-ordination: consultation and guidance by the manager.
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Co-monitoring visits: where the manager evaluates the CRA and provides practical guidance on various matters..R&D has its own quality assurance department, which is responsible, among other duties, for the conduct of internal audits in all projects managed by our CRAs.
Quality Assurance:
All our freshly appointed CRAs have to receive an extended training course on the basics of Clinical Research, ICH GCP Guidelines and Regulations.
Standard Operating Procedures:
Our personnel, as a member receive continuous training on the standard operating procedures.
Therapeutic area training:
Our Medical organise comprehensive training sessions on various therapeutic areas, which are attended by all of our clinical trials and data management staff. Moreover, special medical training is given to all our CRAs prior to their involvement to a project in this particular therapeutic area.
Field training:
Among the training requirements that should be met before a junior R&D CRA can be actively involved with a project, the most practical one is that he or she has to join an experienced CRA on each type of site visit.
Co-monitoring and supervision:
The Clinical Trials Manager is responsible with the task to continuously evaluate and develop the capabilities of the CRAs. Therefore, at R&D, we implement two types of supervision and quality assurance activities: We consistently assure quality in all our monitoring activities, by implementing the following steps.
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