Capabilities

EMMES' interdisciplinary teams provide statistical leadership, study monitoring, data management, quality assurance, information technology, and operational and regulatory support to a distinguished list of clients and collaborators.

Scope of EMMES’ capabilities
The EMMES track record, tabulated in the Capabilities Array, shows our extensive experience in clinical coordination efforts. Individual projects range from 2,000 to more than 24,000 person-hours per year and contracts vary in duration from a few years to several that are more than a decade. For example, our Clinical Trial Support Services contract for the National Cancer Institute’s Cancer Therapy Evaluation Program is now in its twentieth year. More than 100,000 participants and 1,000 medical institutions have been part of the programs EMMES has coordinated.

There are no geographical barriers
EMMES performs clinical research throughout the United States and abroad. Our staff have traveled to and initiated studies in more than 200 cities in the United States and over 20 countries on 6 continents. EMMES successfully operates secure electronic systems for data-capture, verification, and distribution regardless of site locations.

Resources
EMMES specializes in providing support for complex clinical projects. We excel in development and operation of sophisticated computer systems and communication used in all phases of organizing, collecting, managing, interpreting, and reporting data for these projects. Activities that EMMES typically undertakes for these studies are described briefly below.

Collaboration in study design
The scientific value of a clinical research study depends upon an appropriate protocol design. EMMES statisticians and epidemiologists play a pivotal role working with clinical and scientific leaders developing the study protocol. We routinely provide expertise regarding hypothesis generation, outcome definition, sample size determination, randomization techniques, methods to ensure appropriate study masking, and measurement of participant compliance.

Forms development
EMMES has a wealth of experience in the design, development and, pretesting of study forms. Data sources, subject background, "user friendliness", schedules for use, data entry methods, and data verification are all components of forms development. Forms design and testing are performed by our integrated team of statisticians, medical and health professionals, programmers, and data management specialists.

Regulatory
Projects EMMES supports frequently require preparation and submission of Investigational New Drug Applications or Investigational Device Exemptions. Some of these studies result in New Drug Applications or Biologics Licensing Applications or Premarket Approval submissions. Our responsibilities also include preparation and submission of serious adverse event reports and annual reports to the Food and Drug Administration.

All EMMES projects are reviewed by our Institutional Review Board prior to implementation to ensure compliance with the Department of Health and Human Services, Office of Human Research Protection. EMMES is a member of Safe Harbor.

Quality assurance
EMMES collaborates with clinicians in establishing criteria for performance standards, compliance with study protocol, and training of center personnel at all levels of participation. On-site training sessions, materials, and certification procedures are developed, executed, and monitored throughout the study. Our information systems provide timely and thorough data editing features to ensure data integrity and accuracy.

Study participant registration
EMMES has designed and deployed a secure Internet-based Participant Eligibility, Enrollment and Randomization System. This system permits continuous participant enrollment and supports secure transmission using Web browsers. Rapid study participant accrual, eligibility verification, registration, and randomization are high priority procedures that benefit from the EMMES experience in this critical activity. Our systems are designed to protect study participant confidentiality at all levels.

Information technology
EMMES has a broad base of experience with active projects and systems that utilize almost every type of existing computer technology for clinical trial data collection, management, analysis, and reporting. EMMES successfully operates secure electronic systems for data capture, verification, and distribution regardless of site location.