SERVICES

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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 EBS Clinical Research are MDs and their experience and training ensure the highest clinical research standards. Furthermore, our CRAs are locally recruited and 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, EBS Clinical Research assesses the qualifications of physicians and nurses, facilities, pharmacy and laboratory services and access to and availability of appropriate patients

FEASIBILITY & STUDY START-UP SERVICES

At EBS CRO, we understand the importance of determining whether your Investigational Medicinal Product is safe and effective to move to the next phase of clinical development or to be marketed. This is a crucial question for you, your scientific community, patient community, investors, strategic partners, and Competent Authorities in your target markets.
Our Feasibility Unit provides vital input to your decision-making process by determining whether a given protocol version can answer this crucial question and within what timeline and budget. We work closely with you and our Regulatory, Medical, and Proposals teams to base our feasibility assessment on scientific and clinical considerations, data mining of internal and external feasibility databases, and real-time empirical research and re-confirmation of the capabilities and patient pools of our investigator sites.
We are conscious of the importance of:

Laying the foundation for the successful conduct of your clinical trial through our thorough and unique feasibility approach

Offering our established investigational site network for you and re-confirming their patient pool and enrollment potential for your protocol

Including some additional less sought-after sites to filter out and pick the best who can outperform and join our top performer site network

Critically evaluating and assessing every Feasibility Questionnaire and conservatively re-assessing the patient pool and enrollment potential of each site

Obtaining feedback and constructive input about the protocol inclusion/exclusion criteria and study design from the investigators as well as from EBS CRO medical experts and a network of external Key Opinion Leaders in the given therapeutic field

Obtaining feedback from Competent Authorities, IRBs, and ECs about the protocol and the planned recruitment, logistics, financial, and data protection settings of the study

Providing you with feasibility and recruitment options based on different numbers and mixes of countries and sites, protocol, and study settings resulting in different CA and IRB/EC approval, recruitment completion timelines, and study budget scenarios

Helping you leverage our comprehensive feasibility input to develop, refine, and finalize your protocol as an important step forward in your clinical development journey towards delivering your drug to the patients.

RESCUE STRATEGIES

In case of underperforming studies and poor patient recruitment rate EBS 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.

RECORD MANAGEMENT

We are conscious of the importance of:

Clear document management planning, especially during the critical start-up phase of a project

Comprehensive team training

Proactive document management and feedback

Record management services:

Record Management Plan development

TMF/eTMF set up and maintenance

Compliance reporting

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 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

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

Safety and medical management services
Medical Management:

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.