SERVICES

PROJECT MANAGEMENT

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

MONITORING

Most Clinical Research Associates working with EAST BS Clinical Research are MDs 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

SITE MANAGEMENT

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

Timely data entry

Fewer data queries

Better compliance to GCP

SITE ASSESMENT

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.

Successful feasible solutions

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Developing financial options

Financial modeling and analytics

Improving your business planning

Delivering financing solutions

RESCUE STRATEGIES

In case of underperforming studies and poor patient recruitment rate EAST BS Clinical Research can provide advice on the best choice of centers 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

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.

Successful feasible solutions

Developing financial options

Financial modeling and analytics

Improving your business planning

Delivering financing solutions

REGULATORY SERVICES

EBS 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/export licenses for clinical trial materials by finding and liaising with appropriate import/export vendors.

SAFETY AND MEDICAL MANAGEMENT

Our team of skilled professionals has extensive experience in medical management, pharmacovigilance and the regulatory requirements for safety services.
We are conscious of the importance of:
Enrolling eligible subjects:

Implementation of Eligibility Verification-Confirmation Process significantly minimizes the risk of enrolling subjects who do not meet all protocol defined eligibility criteria

Subjects’ safety throughout clinical trial

Continuous and periodic review of safety data and parameters ensure early identification of potential safety signals and implementation of appropriate actions to handle such signals;

Through the 24/7 safety surveillance we are prioritizing subjects’ safety – our experienced medical and pharmacovigilance staff is always available to the Investigators;

Compliance with local, national and international guidelines (including Good Clinical Practice (ICH-GCP)), as well as regulatory requirements. This includes:

An overview of the local and national regulations and guidelines with respect to monitoring and reporting of safety for clinical trials;

What should be reported to whom, when and how.

Eligibility Verification-Confirmation process;

Medical consultations (e.g. eligibility criteria, protocol design, requirements and restrictions);

Review and analysis of safety listings and tables;

Safety signal detection and analysis;

Medical coding.

BIOSTATISTICS

EBS CRO's biostatisticians are constantly updating their knowledge and skills with the latest advancements in the field of biostatistics. We actively participate in, and sometimes even host, conferences focusing on these advancements in order to maintain our competitive edge. Our teams work closely with sponsors, often beginning before a study starts, and maintain a collaborative and proactive approach throughout the study.
At EBS CRO, we assign a dedicated statistician and backup statistician to each study to ensure comprehensive project support and communication. These individuals are supported by a team of two statistical programmers, ensuring thorough validation and consistent high-quality across all study deliverables.