Through our 20 years of successful history, Ergomed has acquired significant experience in both pre-approval and post-approval trials. Our proven service offering ensures that we can provide custom solutions to assist in recruiting patients enrolled on-time and on budget. For Late Phase studies we have a dedicated team to support Real-World Evidence and Observational studies.

Phase I-III

As a full-service provider, we offer a complete solution for trials of nearly any size, location, type or phase.  Our experienced team has years of knowledge in the unique aspects of the most difficult of projects.  We are proud that our full-time staff, of which approximately 25% has a doctorate degree, can provide unique insight into your ongoing and upcoming projects.

We proudly differentiate our Pre-Approval services through:

  • A unique site management model designed to maximise site effectiveness and timelines
  • Study Physician Support to increase communications and improve compliance
  • Extensive development expertise through our dedicated medical teams and expert network
  • A full-service offering to ensure a unified approach to your trial

Real-World Evidence and Late Phase Research

As a part of our full-service capabilities, Ergomed offers complete solutions for Real-World Evidence (RWE) generation studies. Over the past several years, we have accumulated significant experience in:

  • Identifying the gaps in data
  • Designing and implementing RWE studies, including prospective and retrospective data collection within various study types, such as Post-Authorization Safety Studies (PASS) and registries

Our Real-World Evidence services differentiate through:

  • Extensive experience in providing a complete solution for these diverse group of studies
  • Speed and quality, ensured by:
    • Protocol design expertise
    • Unique fit-for-purpose operational strategy plans
    • Tailored data collection and monitoring solutions
  • An approach where we shift the focus to the site and patient needs, ensuring their positive study experience and high quality data

To support these studies, we have developed specific expertise in regulatory affairs, project management and monitoring, site management and other supportive services of peri & post registration study activities. Our scientific, medical and operational experience allows us to develop a fit-for-purpose operational strategy for each project. We also offer tailored data collection options, using many different EDC systems and models, which allows us to find the most appropriate solution to meet the needs of the study.

To learn more about our Real-World Evidence and Late Phase Research capabilities, download our overview brochure.

Services

Project Management / Monitoring

Project Management / Monitoring

Our Project management teams consist of project directors, project managers, clinical team manager, monitors (or clinical research associates) and clinical trial administrators which together form the core of the Ergomed operational organisation.  Besides being highly trained, Ergomed study monitoring teams are recruited locally and based close to the sites they visit. They understand the local culture and are fluent in the local language as well as English, thus ensuring an efficient service that can resolve local issues fast.

Regulatory Affairs / Quality Management

Regulatory Affairs / Quality Management

Ergomed’s Regulatory Team provides a full regulatory service, including the preparation of all regulatory documentation and the provision of regulatory advice on:

  • Registration strategies
  • Regulatory support of clinical trials
  • New Drug Applications (NDA)
  • Compilation and maintenance of Marketing Authorisation Applications.

The team has in-depth knowledge of the country-specific regulatory requirements for clinical trials and observational studies globally. We have developed a database of country requirements, allowing us to forecast the start-up timelines confidently, as well as to pre-empt any potential challenges with study approvals.

Ergomed’s regulatory managers will be responsible for managing all regulatory activities in proposed countries, ensuring timely and accurate submissions are made to each of the applicable Competent Authorities and Ethics Committees, including follow-up as needed. The team is supplemented by a network of local regulatory affiliates and contractors ensuring full compliance with current national and international regulations.

Quality Management System

Ergomed’s Quality Management System comprises three different components. The primary driver is a comprehensive set of SOPs and Policy Documents covering all aspects of Ergomed’s clinical trial related work. Within these documents there are clearly defined quality control checks which must be conducted regularly to ensure on-going compliance.

Secondly it is an independent Quality Assurance Unit, reporting directly to Ergomed’s CEO. The reporting structure is completely separate from Clinical Operations, and thus ensures objective assessment and fully independent audits can be conducted.

Finally, as part of Ergomed’s commitment to Quality, there is a Quality Management Group (QMG), comprising senior operational and regulatory managers, together with QA representatives. The remit of this group is to review issues reported from QC and QA activities to ensure the satisfactory and on-going resolution of errors though training, SOP revision and support in addressing the issue where required.

Data Management / Statistics

Data Management / Statistics

Ergomed offers a full data management service for paper and electronic CRFs for clinical trials (Phase I to IV), non-interventional studies and retrospective data collection. We are co-operating with selected EDC vendors, alternatively we can support your selected eCRF system. Clinical Data Management is performed by experienced teams and the clinical data managers, data associates and database developers have many years of experience in the pharmaceutical and life sciences industries.

The systems and software platforms used are fully validated to comply with international regulations, including 21 CFR Part 11, and are supported by a full complement of IT SOPs. Our services cover the complete range of your trial from Data Management Plan (DMP) and Data Validation Plan (DVP) development through Case Report Form (CRF) development (for both paper and electronic CRFs).

Database design and validation, edit check programming and validation, double data entry (paper CRFs only), query management, medical coding (MedDRA and WHO DD), SAE Reconciliation, external data import (e.g. central laboratory) to interim or final database lock and data export to biostatistics.

Biostatistics

Ergomed offers full biostatistics services for clinical trials (Phase I to IV) and non-interventional studies and retrospective data analysis. Biostatistics is performed by our statisticians who have many years of experience in the pharmaceutical industry and have worked on clinical trials in most therapeutic areas. We use SAS as statistical software, the installations are fully validated as required by international regulations including 21 CRF Part 11.

Our services cover the complete range of your trial from statistical input to the protocol design through randomization, Statistical Analysis Plan (SAP) development, independent statistical support for Data Safety Monitoring Boards (DSMB), Blind Data Review Meetings (BDRM), blinded or unblinded interim analyses, final data analysis, creation of tables, listings and figures for the Clinical Study Report (CSR) to statistical input to the CSR.

We also offer the creation of CDISC SDTM datasets ready for submission to the FDA.

Ergomed’s approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams. This results in a closer relationship between Ergomed and the physicians involved in clinical trials.

Site Management / Study Physicians

Site Management / Study Physicians

Ergomed’s approach to successful Site Management was established over 20 years ago by our company’s founder who was previously a Principal Investigator himself. Ergomed’s assessment and knowledge of the experience of physicians and nurses, investigator facilities, pharmacy and laboratory services significantly improves the access to and the availability of appropriate patients. Ergomed’s Site Management model is an integrated part of Ergomed’s approach to the management of clinical trials.

With over 300 trained Site Coordinators based at sites across Europe and the MENA region. Ergomed has demonstrated high ‘patient-per-site’ ratios as compared to other CROs. Ergomed’s medically led team provides continuous and ongoing site support thereby achieving enhanced patient recruitment rates whilst maintaining data quality. Early and meticulous site evaluation in the feasibility process is critical in ensuring accelerated recruitment.

Our Study Site Coordinators support to investigators results in:

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

Ergomed has successfully rescued complex, under-performing and failing trials across a variety of therapeutic indications. These successes are due to the implementation of our Site Management Model combined with our local knowledge and established relationships with investigators and sites. Ergomed advises on the best country strategies for rapid study set-up and trial execution to deliver a successful turnaround of a failing study.

Study Site Coordinators are identified and trained by Ergomed work at the sites in full compliance with ICH GCP and completely independently of our CRAs and PMs; they follow their own SOPs and have separate line management and reporting structure. The Site Management Model has been audited as part of regulatory audits and has been used in clinical studies Ergomed has completed for clients that have resulted in successful product approvals in USA and Europe.

Study Physician Support

Ergomed has established a Study Physician Team – a highly specialised group of MD’s that deal with the supervision of complicated or demanding therapeutic or diagnostic trials/procedures. All of the MDs that are part of the Study Physician Team have extensive previous clinical practice experience as well as experience in clinical research and drug development.

The presence of an experienced clinician on a study site representing the sponsor improves the understanding of the local investigator of the protocol requirements and improves overall compliance. This speeds up recruitment and lowers the dropout rate. Our Study Physician Team has proven to be highly effective in trials with demanding protocols or study procedures, or low recruitment rates and maintenance of high motivation of the principal investigator is of key importance.

Tasks of the Study Physician Team are:

  • Performing study specific site training
  • Representing Sponsor’s clinical interest at the sites
  • Maintaining good medic to medic relationships with the on-site physicians
  • Supporting investigators in appropriate patient selection
  • Encouraging the sites to seek new study subjects – enhances recruitment
  • Shares the most recent experiences from other sites
  • All potential medical issues are addressed swiftly and resolved

Medical Monitoring

Medical Monitoring

Our Medical Monitors work closely with the project team by supporting the monitoring and communication tasks with the site as well as providing medical safety support.

Our Medical Monitors also perform the following tasks:

  • Review of compliance with the eligibility criteria
  • Review of compliance with the discontinuation criteria
  • Review of safety and medical data
  • Study medication (IMP) administration review
  • Review of protocol deviations and grading (minor, major, critical)
  • Review of data listings for appropriate and consistent coding
  • Review of and input into the CSR
  • Data interpretation and messaging

Medical Writing

Medical Writing

Ergomed has a global team of experienced, native speaker Medical Writers, both in-house and consultants that are available to assist in the development and writing of all your study documents from Protocol and the Patient Information Leaflet / Informed Consent Document, all the way through to the final production and publishing of your final clinical study report. Ergomed MW has robust processes leading to high quality documents within the fastest timelines, that our detailed in our SOPs, and in-house templates that have been developed to comply with ICH GCP and are updated to follow all new requirements and guidance, although we are always open to utilising our clients templates if that is their preference.

The Ergomed Medical Writing team is also available to review, QC and consult on all documents for our clients. Ergomed’s team consists of medical and regulatory writers  across multiple time zones that work alongside and are supported by Ergomed Physicians, Medical Monitors, Statisticians, Data Management, Regulatory Affairs and Quality Assurance.