Multiple Study Data Coordinating Centers for DIPHR

Awarded Vendors: KAI Research Inc.. Contract Award Dollar Amount: IDIQ Max Ceiling - $19,477,245. Contract Award Date: 2018-09-28.

Awarded Vendors: The EMMES Corporation. Contract Award Dollar Amount: IDIQ Max Ceiling - $19,477,245 / Task Order No. 1 - $527,216. Contract Award Date: 2018-09-28.

OFFICIAL SOLICITATION RFP-NIH-NICHD-DIPHR-2018-6.

Added: May 10, 2018 5:33 pm Modified: Jun 11, 2018 8:17 pmTrack Changes OFFICIAL SOLICITATION RFP-NIH-NICHD-DIPHR-2018-6

PLEASE REFER TO DRAFT SOLICITATION RFP-NIH-NICHD-DIPHR-2018-6 posted on May 4, 2018..

Added: May 10, 2018 5:33 pm PLEASE REFER TO DRAFT SOLICITATION RFP-NIH-NICHD-DIPHR-2018-6 posted on May 4, 2018.

THIS IS NOT A REQUEST FOR PROPOSAL (RFP). THIS IS A PRESOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSAL WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT APRIL 9, 2018 IN DRAFT FORM.
The Division of Intramural Population Health Research (DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to solicit proposals to award two Indefinite Delivery Indefinite Quantity (IDIQ) contracts to establish two Data Coordinating Centers (DCCs) with management capabilities to support the original research projects conducted by its intramural investigators. This is a 100% SMALL BUSINESS SET-ASIDE under the NAICS 541715. It is anticipated that the resultant contracts will be cost reimbursement contracts with a seven-year period of performance.
The Division encompasses three branches: 1) Biostatistics & Bioinformatics; 2) Epidemiology, and 3) Health Behavior Branch [https://www.nichd.nih.gov/about/org/diphr/pages/about.aspx]. Central to the Division's mission is to design, implement, and conduct epidemiologic, biobehavioral and biostatistical research. This includes reproductive, perinatal and pediatric epidemiologic research, as well as research addressing gravid women, and child and adolescent health and health behaviors. Original biostatistical and bioinformatics methodology is developed based on analytic problems encountered in the design and/or conduct of the epidemiologic or biobehavioral research. As an intramural entity, the Division is charged with research aimed at filling critical data gaps within its mission by utilizing state-of-the-art methodologies and technologies. In addition, DIPHR investigators are charged with the timely communication of research findings to professional and lay audiences.
DIPHR's research portfolio typically includes 6-10 concurrent major population health studies supported by a DCC through the task order mechanism on the Government fiscal year calendar. DIPHR investigators conduct epidemiologic and biobehavioral research within the following broad domains: etiologic and genetic (e.g., observational) research, clinical trials, complex survey(s) and behavioral studies. Studies involve collection of multiple data types including, for example, biospecimens (e.g., blood, serum, urine, placental tissue, fat tissue, hair samples, saliva), self-report data, electronic data (e.g., using fertility monitors, peak flow meters), imaging (e.g., x-rays, brain imaging, ultrasound images, operative photographs, video from camera-outfitted motor vehicles), wearable devices (e.g., accelerometers), and data collected via smartphones (e.g., ecologic momentary assessment). Sampling frameworks may include targeted clinics, research sites or geographic areas, and may include convenience and population-based sampling. Sampling may be on the individual, population or group level. Data collection often is multi-level, for example, 2-parent dyads, family-based dyads or triads, and classroom-based or school-based sampling units.
The objectives of the proposed contracts are to provide requisite personnel, facilities and services to support all aspects of data collection, management and analysis of large (>500 participants) multicenter population health studies. Major responsibilities of the DCCs will be to assure state-of-the-art data capture and quality, support data collection, tracking, analysis and storage, support all aspects of clinical trials (e.g., randomization, outcome tracking, compliance assessment, and independent monitoring by a Data Safety Monitoring Board (DSMB)), and prepare and submit all necessary reports to DSMBs, Institutional Review Boards (IRBs), regulatory agencies, and the NICHD data repository (DASH).
DIPHR research focuses exclusively on human subjects research 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 RFP is anticipated to be posted on or about April 9, 2018 in draft form on FedBizOpps website: www.fbo.gov. Information in the anticipated RFP supersedes any information in this presolicitation announcement. This acquisition has been designated as 100% Small Business Set-Aside under the North American Industry Classification System (NAICS) code 541715. Any questions concerning this announcement must be submitted electronically to Theresa Koomson, Contracting Officer, at koomsont@mail.nih.gov, or Alice Pagan, Contracting Officer, at pagana@mail.nih.gov. No collect calls will be accepted. This is not an RFP and this announcement does not commit the Government to award a contract. The reference number to be used for this announcement is: RFP-NIH-NICHD-DIPHR-2018-6 All correspondence must cite the reference number as provided.
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Added: Mar 22, 2018 5:53 pm THIS IS NOT A REQUEST FOR PROPOSAL (RFP).  THIS IS A PRESOLICITATION ANNOUNCEMENT ONLY.  A REQUEST FOR PROPOSAL WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT APRIL 9, 2018 IN DRAFT FORM.

The Division of Intramural Population Health Research (DIPHR) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to solicit proposals to award two Indefinite Delivery Indefinite Quantity (IDIQ) contracts to establish two Data Coordinating Centers (DCCs) with management capabilities to support the original research projects conducted by its intramural investigators. This is a 100% SMALL BUSINESS SET-ASIDE under the NAICS 541715. It is anticipated that the resultant contracts will be cost reimbursement contracts with a seven-year period of performance.

The Division encompasses three branches: 1) Biostatistics & Bioinformatics; 2) Epidemiology, and 3) Health Behavior Branch [https://www.nichd.nih.gov/about/org/diphr/pages/about.aspx]. Central to the Division's mission is to design, implement, and conduct epidemiologic, biobehavioral and biostatistical research. This includes reproductive, perinatal and pediatric epidemiologic research, as well as research addressing gravid women, and child and adolescent health and health behaviors. Original biostatistical and bioinformatics methodology is developed based on analytic problems encountered in the design and/or conduct of the epidemiologic or biobehavioral research. As an intramural entity, the Division is charged with research aimed at filling critical data gaps within its mission by utilizing state-of-the-art methodologies and technologies. In addition, DIPHR investigators are charged with the timely communication of research findings to professional and lay audiences.

DIPHR's research portfolio typically includes 6-10 concurrent major population health studies supported by a DCC through the task order mechanism on the Government fiscal year calendar. DIPHR investigators conduct epidemiologic and biobehavioral research within the following broad domains: etiologic and genetic (e.g., observational) research, clinical trials, complex survey(s) and behavioral studies. Studies involve collection of multiple data types including, for example, biospecimens (e.g., blood, serum, urine, placental tissue, fat tissue, hair samples, saliva), self-report data, electronic data (e.g., using fertility monitors, peak flow meters), imaging (e.g., x-rays, brain imaging, ultrasound images, operative photographs, video from camera-outfitted motor vehicles), wearable devices (e.g., accelerometers), and data collected via smartphones (e.g., ecologic momentary assessment). Sampling frameworks may include targeted clinics, research sites or geographic areas, and may include convenience and population-based sampling. Sampling may be on the individual, population or group level. Data collection often is multi-level, for example, 2-parent dyads, family-based dyads or triads, and classroom-based or school-based sampling units.

The objectives of the proposed contracts are to provide requisite personnel, facilities and services to support all aspects of data collection, management and analysis of large (>500 participants) multicenter population health studies. Major responsibilities of the DCCs will be to assure state-of-the-art data capture and quality, support data collection, tracking, analysis and storage, support all aspects of clinical trials (e.g., randomization, outcome tracking, compliance assessment, and independent monitoring by a Data Safety Monitoring Board (DSMB)), and prepare and submit all necessary reports to DSMBs, Institutional Review Boards (IRBs), regulatory agencies, and the NICHD data repository (DASH).

DIPHR research focuses exclusively on human subjects research 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 RFP is anticipated to be posted on or about April 9, 2018 in draft form on FedBizOpps website: www.fbo.gov. Information in the anticipated RFP supersedes any information in this presolicitation announcement. This acquisition has been designated as 100% Small Business Set-Aside under the North American Industry Classification System (NAICS) code 541715. Any questions concerning this announcement must be submitted electronically to Theresa Koomson, Contracting Officer, at koomsont@mail.nih.gov, or Alice Pagan, Contracting Officer, at pagana@mail.nih.gov. No collect calls will be accepted. This is not an RFP and this announcement does not commit the Government to award a contract. The reference number to be used for this announcement is: RFP-NIH-NICHD-DIPHR-2018-6 All correspondence must cite the reference number as provided.