Operational Capabilities & Services

With a network of over large number of faculty staff and accredited investigators and sites in almost every specialty, the Foundation is capable of conducting any clinical research project, from the smallest proof of concept study to part of global mega-trials; from medical device trials, to hard endpoints and quality of life analyses. Our experience stretches from Phase I to Phase IV and includes post approval analyses and health economics.

Clinical Operation

The Foundation’s knowledgeable Clinical Operations Management teams have coordinated significant and pioneering trials in the Northern, Central & Eastern European areas and Middle East and North Africa Region. This experience provides the Foundations Site Management teams with unequalled knowledge and processes, which have withstood the test of research ranging from small, regional studies to mega-trials. The Foundation’s KOL driven study implementation and oversight process proven study sites, which are also supervised by the relevant Faculty member, is a valuable resource, giving sponsors confidence in the quality and recruitment progress at the networked centers.

The Foundation also offers immediate access to a senior academic member of the Advisory Board who is thoroughly familiar with the study drug, indication and the clinical trial protocol. This is augmented by a large number of KOLs in different specialties. A member of the Advisory Board is available 24/7 to assist investigational sites with pressing protocol questions, or the care of the patients enrolled in the trial conducted under the auspices of the Foundation. This results in a greater number of completers and a reduced risk of protocol violations that some projects elsewhere have experienced in the past. Having a centralised, rapid access to a senior clinician with expertise in both the indication and the clinical trial protocol enhances recruitment, increases protocol compliance, and significantly reduces the incidence of unbinding. This facility enables the early identification of trends in adverse events, or protocol issues allowing significant and clinically important protocol amendments.
The wide-ranging services of the Foundation include outstanding site management and clinical monitoring capabilities. Our Site Management teams are clinically skilled, so that they are both innovative but aligned to with the needs of clients, patients, and investigators alike. The results are efficient site services that accelerate recruitment and study implementation. The monitoring teams are all capable of undertaking Investigator qualification/selection to the Foundation criteria and facilitation of clinical trial enrollment while ensuring site regulatory compliance.

Drug Safety

Quality Assurance

The Foundation Team has a group of expert independent auditors, based in Germany and Latvia, who audit Investigator Sites and a variety of Vendors.  The group also provide Investigator and Clinical Team GCP training.  The revisions of ICH E6(R2) will place greater emphasis on sponsor responsibility for clinical monitoring and the audit team provide regular independent audits and reviews of Clinical Monitor activities ensuring compliance ICH E6(R2).

This service is also available to sponsors to provide an independent assessment of standards of monitoring for sponsors with projects underway with either their own teams of other CROs.

Education

A further important role of the Foundation is in its sponsorship of talented young medical professionals in the Eastern European Area. The Foundation arranges financial support, education and training, hence facilitating the development of the appropriate level of knowledge and skills in both clinical research and medical care in the region. A core component of this programme is to develop interactive evidence-based conferences with prominent speakers to make available to physicians, pharmacists, nurses, and clinical support staff the latest information related to better clinical practice, treatment guidelines and clinical research expertise.
Through its range of activities Foundation aims to leverage the expertise of the Academic Board and the unique structure of its clinical research network to provide sponsors with access to an exceptional organisation in Central & Eastern Europe and Middle East and North Africa Region. that is dedicated to clinical and academic research excellence.