Covering the All-Round Management of Clinical Trial Sites
We offer site management services in Central and Eastern European (CEE) countries to companies intending to conduct clinical trials in this region. Our offering in this area is aimed at small and medium sized pharmaceutical and biotech companies looking for assistance and a like-minded partner with an ethos of treating every client special and providing bespoke site management services as opposed to the “one-size-fits-all” approach associated with large site-management-organisations.
The availability of willing patients, very experienced researchers and EMA-compliant legislation make the CEE region an attractive clinical trial site destination. The general feedback continues to suggest that the high productivity of CEE sites is accompanied by regulatory compliance and data quality standards that match those in Western regions.
Our streamlined and integrated site management services are delivered by a dedicated network of professionals with industry and therapeutic area expertise across all phases of clinical development. This, coupled with our in-depth understanding of operations in the CEE countries and strong relationships with trial sites, results in an efficient and effective trial start and recruitment of patients to achieve your
Stridon’s clinical site management services include:
- Site selection and feasibility
- Site contract and budget management
- Preparation of site specific documentation
- Ethics Committee and Regulatory submissions
- Subject recruitment and retention management
- Generic and study specific training for clinical trial staff
- Coordination of clinical trial medication supplies
- Clinical trial monitoring
- Assurance of good clinical practice
- Site communication strategy and progress reporting
- Subject safety management
- Third party vendor management
Additional services may be included depending on the client’s needs, providing assistance in preparing sites for clinical trials and ensuring that logistical, regulatory and ethical requirements are met. Such other services may include site Standard Operating Procedure (SOP) writing, arranging for Case Report Form (CRF) development and data management services, organising laboratory sample analyses and documentation archiving.
Our operational personnel is field based throughout the CEE region, not only to limit travel and support the project team, but primarily to leverage local knowledge of the clinical research and regulatory environments. They focus on developing strong site relationships while ensuring the site’s adherence to data quality, subject safety and early issue resolution throughout the course of the trial.
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