Our Project Management ensures that all studies are carried out in full accordance with the study protocol, to agreed study timelines, and to other Sponsor-driven parameters.

Project Management responsibilities include:

• Maintaining primary contact with the Sponsor
• Taking overall responsibility for all procedures and processes throughout the whole study period
• Selection and management of project team members (CRAs, as well as CTAs)
• Selection of sites/investigators in agreement with the Sponsor
• Set up and control of pre-study visits, site initiations, monitoring and close-out visits
• Regularly reporting study status to Sponsors
• Overseeing preparation and distribution of newsletters to investigators
• Organization of Project/CRA/Investigator/Client Meetings

Most Clinical Research Associates working with EAST BS Clinical Research are MDs or PhDs and their experience and training ensure the highest clinical research standards. Furthermore, our CRAs are locally recruited which means that they are fluent in both local and in English language which ensures services of the highest quality.

Responsibilities of CRAs include:

• Ensuring that Informed Consent has been signed by all patients recruited
• Performing Source Data Verification (SDV) on the CRFs.
• Monitoring drug accountability and authorizing drug returns
• Ensuring that the site documentation is complete and accurate in the site file
• Ensuring that sufficient study materials are in stock at all times
• Reviewing, reporting and discussing patient recruitment progress and any recruitment issues with on-site personnel
• Visiting the laboratory and the pharmacy as appropriate
• Transferring completed CRFs to the relevant Data Management function

Our approach to Site Management ensures effective patient recruitment with high recruitment rate and reduced time and cost of clinical trials.

The results are:

• Faster recruitment
• More patients per site
• Enhanced data quality
• More timely data entry
• Fewer data queries
• Better compliance to GCP

Site selection is the most important step for ensuring both timely recruitment and high-quality study data, therefore we screen and assess sites extensively before including them in studies. In addition, EAST BS Clinical Research assesses the qualifications of physicians and nurses, facilities, pharmacy and laboratory services and access to and availability of appropriate patients.

In case of underperforming studies and poor patient recruitment rate EAST BS Clinical Research can provide advice on the best choice of centres for rapid study set-up and execution.

Our rescue strategies can deliver:

• Accelerated and enhanced patient enrolment
• High quality data generation
• Well trained and experienced investigators

Pharmacovigilance and drug safety complement other services provided by CRO and include services such as identifying, recording and reporting SAEs/SUSARs according to applicable regulations.

EAST BS Clinical Research is able to provide full support for all regulatory and ethics submissions. The services include:

• Preparation and submission of study documentation in accordance with requirements of Regulatory Authorities and Ethics Committees
• Preparation and translation of core clinical documents including country specific SIS/ICFs
• Preparation and translation of drug labels to ensure compliance with local GMP requirements
• Sourcing of local insurance policies
• Review of documents from external sources to ensure compliance with local guidelines/laws/regulations
• Obtaining import licenses for clinical trial materials