SERVICESPlanning, preparation/review of clinical development plans, study manuals, protocols for small and medium-size pharmaceutical and biotechnology companies and academic institutions wishing to develop their drugs in Europe.
We can manage particularly complex trials or rescue trials that have overrun their timelines and/or budgets.
The execution, conduct and controlling of all project parties, regular reporting to the customer and risk identification/reporting and mitigation.
Projects
By using a network of highly experience monitors in Europe, we help you to identify suitable countries and sites to execute clinical trials, and to obtain study authorizations from competent authorities and ethics committees.
The monitors will regularly communicate with the sites and perform basic or risk-adapted monitoring visits.
We help to develop unique, project specific trainings to ensure in a few steps that the site is well-prepared, trained and encouraged to recruit as many patients as possible.
Whether you are in need of a single Clinical Project Manager to cover a peak in the development activity or an entire team of CRAs to address an unforeseen study need, or you wish to partner with a Functional Service Provider, we are able to successfully provide you with customised resourcing solutions which will meet your needs.
The vendors work under umbrella contracts with Spapharm s.r.o. according to the specific requirements of the individual studies. We have developed a consistent approach to vendor management, with full transparency right from the RFP process, which continues through the contracting process, vendor management during the project execution and the contract and project closure, ensuring no surprises on either side.
We can offer you our experience with vendors or selection based on reliable recommendations.
