Added: March 27, 2008
The Division of Epidemiology, Statistics and Prevention Research (DESPR) of the Eunice Kennedy Schriver National Institute of Child Health and Human Development (NIHCD, National Institutes of Health (NIH), Department of Health and Human Services (DHHS), intends to award a contract for a data coordinating and management center to support the original research projects conducted by its investigators . This is a 100% SMALL BUSINESS SET-ASIDE, NAICS 541712 with a size standard of 500 employees or less. It is anticipated that one indefinite delivery /indefinite quantity (IDIQ), cost reimbursement contract will be awarded for a 5-year period with performance beginning on or about September 15, 2008.
The Division of Epidemiology, Statistics and Prevention Research (DESPR) of the Eunice Kennedy Schriver National Institute of Child Health and Human Development (NIHCD) proposes to establish a web based data coordinating and management center to support the original research projects conducted by its investigators. The Division encompasses three branches: 1) Epidemiology Branch; 2) Biometry Branch and 3) Prevention Research Branch [http://www.nichd.nih.gov/about/org/despr/]. Central to the DESPRs mission is to design, implement, and direct epidemiologic, behavioral and biostatistical research. This includes reproductive, perinatal and pediatric epidemiologic research as well as research addressing child and adolescent health behaviors. Original biostatistical methods also are developed motivated by analytic problems encountered in the design or conduct of the epidemiologic or health behavioral research. As an intramural Division, DESPR is charged with research aimed at answering critical data gaps within its mission by utilizing state-of-the-art methodologies and technologies. In addition, DESPR investigators are charged with the timely communication of research findings to both professional and lay audiences. The Division typically implements 1-3 new studies annually on a government fiscal year basis subject to funding, with each study lasting from approximately 2-5 years. This includes both epidemiologic and health behavioral research within the following broad domains and as described below: etiologic research; clinical prediction; clinical efficacy or intervention trials; behavioral intervention trials with randomization at the individual or family/school level.
The objectives of this contract are for the NICHD to obtain on behalf of DESPR: 1) a state-of-the-art web based data coordination and management system that offer access to all aspects of the data for each study in real time capable; 2) the ability of the web based data management system to track biospecimens or other types of data that may be collected in clinical sites or in study participants homes; 3) the production of a fully documented mega data file, supporting data files including quality assurance documentation and analytic files or other requirements as needed; 4) the ability to provide or subcontract for specific biostatistical methologic expertise and/or laboratory analyses as required for each study; and 5) the ability to provide other essential logistical support such as scheduling conference calls, steering committee meetings or data safety and monitoring boards (DSMBs) meetings along with the preparation of minutes for all such activities.
The Epidemiology and Prevention Research Branches typically conduct research that utilizes one of two types of designs. First is the prospective cohort design for the longitudinal collection of data (particularly at critical or sensitive windows within human reproduction and development), biospecimens, third party data (e.g., fertility monitors or other PDA-type devices), and increasingly digital data (e.g., x-rays, MRIs, operative photographs, camera outfitted motor vehicles for young drivers). Other important aspects of human reproduction and development that impact data base design and management is the couple dependent approach for data collection and analysis and the clustering of reproductive and pregnancy outcomes. Study covariates are frequently time-varying and further dictate data structure. In addition, the Prevention Research Branch often randomizes clusters (e.g., schools, summer camps) underscoring the importance of a data structure suitable for the implementation of hierarchical modeling. Some research involves individuals while other research involves couples or families. Hence, the ability of the offeror to support individual or higher order units of analysis is essential. The second typical study design is the randomized trial. The Epidemiology Branch conducts both randomized clinical trials aimed at assessing clinical efficacy or intervention trials. The Prevention Research Branch typically conducts intervention trials involving individuals, families, summer camps, or schools as the randomization unit.
General Notes to Offerors:
*The web based data management structure should be able to accommodate up to three new studies annually with each lasting from 2-5 years. Studies largely involve prospective (observational) cohort designs or randomized trials. Longitudinal capture of data from multiple sources and biospecimens is typically a part of the DESPRs research portfolio.
*The web based data management system shall accommodate each project but ensure the flexibility to meet specific needs per forthcoming studies protocols. The web based system should have the following characteristics: 1) flexible data collection including the ability to upload files from multiple sites or sources (e.g., labs, clinical facilities, study participants homes); 2) ability to accommodate multiple remote users (e.g., study participants entering data from homes) including flexibility in accommodating varying browsers; 3) ability to accommodate varying types of data including digital files; 4) ability to provide or subcontract of expert biostatistical or laboratory services as requested by the Government per the studys needs; 5) ability to provide logistical support for the scheduling, hosting and minute taking of steering committee meetings, DSMBs, and similar activities; and 6) ability to deliver interim and final databases and supporting documentation in formats requested by the government.
*DESPR intends for the successful offeror to be physically located offsite, but to have or establish a local office available within a 50-mile radius of 6100 Executive Blvd., Rockville, MD to facilitate regular interaction and in-person meetings needed for maximizing success.
*The first two projects (FY08 and FY09 starts) are both prospective cohort studies involving newly pregnant women who will be followed through pregnancy and delivery (or pregnancy loss). Longitudinal collection of data from multiple sources (e.g., women completing self administered questionnaires or structured interviews, medical record abstraction, pregnancy journals, ultrasonography, Doppler measurements) is planned along with the collection of biospecimens (e.g., blood, urine, buccal swabs) at repeated intervals timed to gestation. Approximately 3,000 women will be recruited in each of the two studies. Digital diagnostic files (e.g., ultrasounds, Doppler measurements) are expected for both studies. Subcontracting for laboratory research is also anticipated for both projects along with biostatistical expertise in repeated measurement analysis, longitudinal analysis, and in Bioinformatics.
*Two to three new research projects are anticipated for FY10 of which one is likely to include a randomize trial design. All will be prospective in design with longitudinal capture of a multitude of data, digital files and biospecimens.
*DESPRs research focuses exclusively on people and, as such, the offeror must have proven expertise in the preparation of study materials needed for obtaining (often multiple) institutional review boards, Office of Management & Budget (OMB) applications, certificates of confidentiality, investigational new drug (IND) applications, and other necessary documentation. In addition, proven expertise in the development and maintenance of manual of procedures (MOP) is required. Changes to the MOP are expected to be documented in real time within the web based data management structure and to remain as a part of the official audit trail.
*Key personnel shall be designated specifically for each Task and may include the Principal Investigator, Study Manager, Biostatistician, Web Programmer and/or Data Manager.
The purpose of this announcement is to inform interested organizations of a planned Request for Proposals (RFP). This announcement is NOT an RFP. This is a 100% Small Business Set-Aside. It is anticipated that one award indefinite delivery /indefinite quantity (IDIQ), cost reimbursement contract will be awarded for a 5-year period with performance beginning on or about September 15, 2008. RFP-NIH-NICHD-DESPR-08-29 will be available electronically on or about April 10, 2008, with a closing date tentatively set for May 26, 2008 and may be accessed through the FedBizOpps website: www.fbo.gov. Offerors are responsible for routinely checking this website for any amendments to the solicitation. Any questions concerning this announcement must be submitted in writing to Rukshani Fernando, Contract Specialist, at rf212s@nih.gov or addressed to Ms. Rukshani Fernando, Office of Acquisitions, NIDDK, NICHD Branch, Executive Blvd., Suite 7A07L , MSC 7510 Bethesda, Maryland 20892-7510. If sending by overnight carrier, use Rockville, Maryland 20852. The secondary point of contact is Elizabeth Osinski, Contracting Officer, at eo43m@nih.gov at the same address as above. No phone calls will be accepted.
