Medical Writing, Report Preparation & Project Management

This is a SOURCES SOUGHT NOTICE to determine the availability of small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) that can provide medical writing to include a) protocol development, b) preparation of summary statistical analysis plans, c) preparation of data safety and monitoring board (DSMB) reports, preparation of clinical study reports d) coordination of final clinical study reports, and e) manuscript writing in support of Phase I, Phase II, and/or Phase III clinical trials managed and coordinated by NIDA. Information sent must be in writing and should be relevant and specific to the above technical area, on each of the following qualifications: (1) Experience: An outline of previous similar projects (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct this type of work. Capability statements should include any other specific and relevant information about this planned procurement to improve our knowledge of offerors capabilities. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organization's capability, e.g., awards, commendations, etc. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a request for proposals. The Government neither intends to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information submitted for the Government's use. Any proprietary information should be so marked. Interested organizations submitting a capability statement in response to this sources sought announcement must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes, 5) business size and status; 6) capability information in response to the requirement and 7) type of small business. Please submit written capability statements by November 13, 2009 to the NIDA Contracting Officer at the address below: If using U.S. Postal Service: Craig Sager, Contracting Officer National Institute on Drug Abuse, NIH NIDA R&D Contracts Management Branch Neurosciences Office of Acquisition 6101 Executive Boulevard Room 260, MSC 8402 Bethesda, Maryland 20892-8402 Or, if hand delivered or delivery service: Craig Sager, Contracting Officer National Institute on Drug Abuse, NIH NIDA R&D Contracts Management Branch Neurosciences Office of Acquisition 6101 Executive Boulevard, Room 260 Rockville, Maryland 20852