…pharmaceutical wholesalers experienced in complex quality assurance, logistics, manufacturing and distribution tasks are becoming more and more important contributors to international clinical trials. As a result of the increasing tendency of sponsors and contract research organizations (CROs) to switch from central to local sourcing strategies, we have been given the opportunity to work with an increasing number of international companies within the realm of international clinical trials as well…
All products bound to be commercialized need to be subjected to rigorous international clinical trials to verify their biological effect, tolerability, safety, pharmacokinetics and pharmacodynamics before their registration is granted by the authorities. Given their complexity, these multi-country international clinical trials are quite expensive hence cost-efficiency has become an important factor in organizing them. As part of their efforts to curb costs as much as possible, sponsors and contract research organizations frequently opt for a local- as opposed to a central sourcing strategy. This means that instead of contracting with one large-scale service provider responsible for all required tasks globally they choose to partner up with multiple local operators to perform such tasks in their own national markets respectively.
Over the last five years, our company has become a verified supplier of several sponsors, marketing authorizations holders as well as contract research organizations. Our colleagues are well trained in all aspects of the procurement, logistic and documentary requirements of international clinical trials and annually renew their certification in Good Clinical Practices. Some of our experts involved in the coordination of international clinical trials are also certified as Clinical Research Auditors by the International Accrediting Organization for Clinical Research (IAOCR). At the recent expansion of our main facility the specific service requirements of our clinical research focused clients have also been considered including any potential manufacturing-oriented needs concerning labelling or the manipulation of secondary packaging.
Our expertise within the realm of clinical trial supply include the following services:
- Importation and administration of investigational medicinal products;
- Storage of investigational medicinal products;
- Distribution of investigational medicinal products to investigator sites;
- Procurement, storage and distribution to investigator sites of all related product categories (comparators, rescue medicine, ancillary products, etc.);
- Manufacturing services (labelling, repacking, any forms of manipulation regarding the primary and secondary packaging, etc.);
- Administration of all aspects of clinical trial supply services (procurement, importation, storage, transportation, distribution, reporting, return, destruction, etc.) on a project basis supported by dedicated personnel with GCP and other certifications.