Functional Groups

FUNCTIONAL GROUPS

EMMES' professional staff is organized into functional groups; each group is centered on a set of common project skills, described below.

Statistical direction
The statistical group provides professional leadership in study design, interim monitoring, selection and execution of statistical analysis, and interpretation and presentation of data.  Statisticians also provide training and instruction to internal and external staff.  Study participant safety, data quality, and site performance are subject to continuous review by this group.

Data coordination and protocol monitoring
The data coordination and protocol monitoring group is responsible for training and oversight of clinical research associates, implementing regulatory procedures, drug distribution and specimen processing procedures, recruitment and on-site quality assurance monitoring, producing and routing safety reports, and other tasks related to the protocol-specified conduct of the clinical study.

Uniquely qualified staff members enhance EMMES' capabilities even further.   Our Director of Clinical Quality Assurance ensures that EMMES' employees have a strong foundation in good clinical practices as they apply to the operations of a coordinating center and clinical site monitoring.  EMMES' Project Director for Ophthalmic Training and Certification heads an experienced staff who conducts Site Certification Examinations for clinic personnel participating in domestic and international studies sponsored by NIH and leading pharmaceutical companies.

Regulatory affairs
Our Chief Medical Officer is Director of EMMES' Regulatory Affairs Department.   The regulatory group is responsible for preparation, review, and compilation of documents for regulatory submissions as well as oversight and tracking of regulatory documents from investigative sites.  Regulatory submissions have included IND, NDA, biologics and medical device applications or amendments for industry, government, and investigator-sponsored programs.  EMMES' regulatory staff participates in development and reviews of protocols, investigational plans, investigator brochures, pre-clinical and clinical data, manufacturing information, and safety monitoring procedures.

Information technology
EMMES' IT professionals play an essential role in the support of clinical trials.  Their initial goal is to analyze the client's systems requirements and to develop novel software integrated with the best commercially available products.  The objective is to construct a responsive and reliable data capture and informatics platform supporting the collection of high-quality research data, thereby facilitating analyses by EMMES' statisticians and data managers.  System documentation, security integrity, and study participant confidentiality are an integral component of EMMES' corporate platforms.   Our systems have been found in compliance with 21 CFR Part 11.

Our Director of Computer Systems and Director of Software Development focus the efforts of the EMMES system analysis staff on software system design and analysis as it applies to clinical research.  Their experience with full life-cycle software development and relational DBMS and GUI design for Internet and client-server applications provide EMMES systems with the creative advantage to uniquely meet the challenges of system integration.

Administrative support
Administrative Coordinators provide the underlying structure for effective project function by establishing the organizational support required, and by ensuring efficient communications and information dissemination.   Our staff schedules and manages conference calls and meetings, and prepares and maintains hard-copy and electronic document distribution of operations manuals, protocols, and other necessary reports and information.

Contract support
Our project teams are supported by professional contract administrators.   The Vice President of Finance provides overall corporate support and oversight to our Contracts Administration team.  EMMES' administrative performance is as important as our technical and scientific performance.  We are proud to provide our clients with a well-rounded and responsive service package.