Clinical Research Management, Inc.

Clinical Research Management, Inc. (CRM) is a privately-held Clinical Research Organization that is dedicated to providing top quality, efficient, and cost-effective development services to the Pharmaceutical and Biotech Industries. At CRM we believe that every client's needs are unique and deserving of personalized attention.

Our approach is to work closely with each client to identify immediate, near-term, and long-term program requirements - then to create specific project teams designed to meet these needs. We hand-pick the team members best suited to each project from our cadre of regional clinical research professionals. As a client's needs change, we can dynamically adjust the roster of clinical research professionals assigned to the project, matching the expertise and talents of the individual team members to program demands.

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• Our Clinical Research Professionals are highly experienced. The majority of CRM staff has more than 7 years of successful field experience in a wide range of therapeutic areas.
• Contract Study Monitoring is provided through our regional network of Quality-Assured Clinical Research Associates.
• CRM Project Managers undergo rigorous training, and most have come up through the CRA ranks. They know exactly what it takes to make a program successful in the real world.
• CRM Medical Officers have extensive expertise in evaluating, managing and reporting safety information for IND programs, NDA/BLAs, and Postmarketing Surveillance.
• Medical Writing services are provided by a well-trained, experienced group of contract medical writers having diverse therapeutic area and development phase experience.




Our team of well-trained and detail-oriented GCP Auditors provide site auditing services for study closeouts, NDA/BLA preparation, as well as pre-emptive audits for cause. CRM also provides ongoing Regulatory Affairs, CMC, and Preclinical support to clients on a project or program-specific basis, through our network of affiliated Regulatory Affairs and Development Professionals.

CRM, Inc provides services in a flexible, "cafeteria-style" way - each client chooses only those services they want or need. Our reporting requirements are flexible too:

• CRM staff can report directly to the client
• They may be part of a team handled by a CRM Project Manager who reports to the client
• CRM can also provide complete, turn-key operations, where we handle all of your program demands.

Our flexible approach to staffing and management allows us to match the right CRA(s) and degree of management oversight to the task at hand, maximizing the timeliness, quality and effectiveness of communication and clinical development for each client. In addition to long-term contract for clinical monitoring of single- or multi-center trials, CRM, Inc. often provides short-term contract support for projects where clients are unable to commit full-time internal resources.

For example:

• Projects in transition from early stage development to phase I or II development
• Phase III cloesouts to meet submission deadlines
• Projects being initiated before permanent staff resources are allocated
• Overload staffing for time-critical program closeouts.

Early-Stage Clinical Development

• Protocol Development and CRF Design
• IND Preparation and Submission
• Preparation of Comprehensive Product Development Plans
• Evaluation of Data Management Plans
• Preparation of Statistical Analysis Plans
• Assessment of potential new chemical entities and clinical development candidates

Clinical Operations

• Study Monitoring, Project and Program Management
• Clinical Drug / Device Supply Management
• Study Site Evaluation and GCP/ICH Compliance Audits
• Study Site and Regulatory (GCP/ICH) Training
• IND Safety Report Tracking and Management
• Medical Safety Surveillance / Pharmacovigilance
• IND program Annual Reports
• Study File Management and Document Scanning
• Electronic Documents for eSubmissions

Clinical Research Activities

• Medical Writing - All Phases
• Data Interpretation / Summarization
• Data Management
• Statistics and Programming

Late Stage Development Services

• Preparation for FDA Meetings
• NDA / BLA / CTD Development
• Advisory Committee Preparation and Training
• Presentation and Poster Development
• Manuscripts

CRM, Inc's Corporate Headquarters is located in Agawam, MA, near Springfield MA. This 7500 sq. ft. facility includes the CRM Archive (secure clients document storage), coordination of project management and monitoring services, document scanning capabilities, as well as office, meeting and conference facilities.

The Electronic Document Center and the headquarters for the Medical Writing Group are located in Providence, RI.

Statistical and programming services are provided by MatStat Consulting, LLC in Fair Lawn, NJ, while data management activities are provided by several alliance partners including Quartesian Inc. and PharmData Inc.

Regional CRAs are located in the Northeast, Midwest, Southwest and on the West Coast.

• Each Regional CRA works out of a fully-equipped home office, with email, internet access, cellular and fax capability.
• Standard Operating Procedures insure consistency and reliability of communications between CRM staff and study sites, client locations and CRM headquarters.
• Regional CRAs, Medical Writers, Statisticians and Data Managers are also available for client meetings - prestudy training, study initiations, investigator meetings, and other centralized meeting as required by the client

Contact Information

Clinical Research Management, Inc.
Stephen Cincotta, President & CEO
1408 Main Street
Agawam, MA 01001 USA
Phone: 413-821-0022 x 11
Fax: 413-821-0040
E-mail:

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