JA - Non-RD - NCI - Clinical Trials Monitoring Services - Redacted v.2.pdf

9609 Medical Center Drive, Room 5W-334 Rockville, MD 20892

E-mail address gs44h@nih.gov

Telephone number

(240) 276-6545

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The purpose of this acquisition is to increase the level of effort for Option Period 4/Year 5 of the Theradex Systems, Inc. contract HHSN261201700009C in order to accommodate an increased workload related to:

1. COVID-19 Cancer Study Activities

2. Integration of Biomarker Data with Clinical Data

3. Moonshot Biobank related activities

b. Project background.

The mission of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anticancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects.

This acquisition will assist the Cancer Therapy Evaluation Program (CTEP) in fulf illing its responsibilities as an sponsor and funding agency with respect to Food and Drug Administration (FDA) and HHS regulations. The scope of this contract is to provide data management, quality assurance, clinical trial monitoring and auditing capability for NCI sponsored clinical trials at participating sites both within and outside of the U.S. and to provide mechanisms for auditing of biopharmaceutical manufacturing facilities to ensure compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

The Clinical Trials Monitoring Service (CTMS) contract is responsible for: 1) providing a centralized patient registry, protocol patient data capture system using Medidata Rave, and a quality control review process for early phase clinical trials including Phase 0, Phase 1, Phase 2 and randomized Phase 2 clinical trials conducted by N Experimental Therapeutics Clinical Trials Network (ETCTN) and other NCI supported early phase clinical trials networks; 2) conducting monitoring visits of ETCTN sites to ensure compliance with regulatory and protocol requirements and to ensure the

Justification and Approval is to extend these activities for Option Period 4 due to the increased work demands on the current contract.

Integration of Biomarker Data with Clinical Data (Free the Data) ility of clinical and molecular data from NCI-supported treatm project includes efforts to make early clinical trial data available to outside researchers in a controlled access environment; and efforts to facilitate processes and mechanisms to enable the biomarker and molecular data to be integrated with the clinical data in the web reporting module with the goal of making this data available in the NCI clinical trials data archives (NCTN/ETCTN/NCORP Archive, GDC, CIDC, Navigator).

In order to support the initiative, the Contractor shall expand on the Web Reporting System and implement a process for making both clinical and biomarker data available in a controlled access database for outside investigators (researchers who are not part of the Study Team on a given protocol) to perform secondary analysis. The availability of the data to outside researchers/investigators must only occur after the primary objectives of the study have been met and data published.

The Contractor shall integrate with the current NCTN/NCORP/ETCTN Archive, Genomic Data Commons, Cancer Immune Monitoring and Analysis Center, and Navigator.

Moonshot Biobank ActivitiesSM

The contract currently supports limited activities related to the Cancer Moonshot Biobank Project due to unavailability of adequate level-of-effort.

The objective of the Moonshot Biobank is to support research by establishing the infrastructure for longitudinal biospecimen collections from a diverse patient population engaged at multiple medical institutions in the U.S. The program will work with community hospitals to engage and consent eligible patients, collect biospecimens, perform pathology quality control and to identify an organization to provide centralized biobanking. The Biobank protocol includes the performance of a clinical tumor molecular characterization assay with return of those results to the biospecimens and associated data available to researchers to accelerate progress in treating cancer.

The planned activities related to Moonshot Biobank initiative that need to be completed in Option Period 4 that will require increased level-of- effort include:

1) IT development work:

a. Integration with BSI (Biorepository LIMS)

b. Integration with Online Catalog for the Moonshot Biobank

c. Updating Case Report Forms for the study as necessary

d. Programming work to ensure sites submit accurate data (and samples) for the study

2) Data Management

3) Facilitating data downloads and data sharing efforts to submit data to

4) The moonshot biobank project was launched in September 2020, thus far four (4) patients have been enrolled. Engagement efforts are underway to improve enrollment in 2021.

Requirement type. Check the appropriate box:

Research & development (R&D) R & D support services

X Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action. Check the appropriate box:

New requirement Follow-on

X Other (specify): Modification to active contract (requirement for additional level of effort

Proposed contract/order type. Check all that apply:

Firm-f ixed-price Other f ixed-price (specify, e.g., f ixed-price award-fee, f ixed-price incentive-fee): __________ X Cost-plus-fixed-fee

Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________

Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form X Term form

Acquisition identification number. N/A

c. Total estimated dollar value and performance/delivery period.

This J&A would result in the addition of labor hours to the Option Period 4 of the existing Cost-Plus Fixed Fee Level of Effort contract entitled: Clinical Trials Monitoring Service, HHSN26120170009C

(NCCAPS), the integration biomarker data with Clinical Data, and Moonshot biobank project are all ongoing activities.

The Moonshot Biobank related activities were originally implemented in September 2020 and funded through 21st Century Cures Act utilizing existing additional capacity options for level of effort in the contract. However, the increasing demands for the work originally negotiated, Moonshot work and COVID-19 related work have exhausted the existing additional capacity options. This justification & approval would provide additional level of effort and funding for Option Period 4 of the contract and the work for Moonshot and COVID-19 activities. The addition of another contractor performing the same work would result in the need for additional IT integrations resulting in delays which are unacceptable given the high priority of these on-going studies.

With regards to the integration of biomarker data with Clinical Data, Theradex maintains the database containing the clinical data so that any work related to integration of clinical data with biomarker data is dependent on Theradex. Knowledge acquisition sessions with the contractor (Theradex), representatives from the Division of Cancer

(CTEP) ,Cancer Diagnosis Program (CDP) and the Frederick National Laboratory for Cancer Research have been conducted every two weeks as a one hour teleconference over the past 24 months in developing an approach for integration. Thus far, a pilot project using CBioPortal has been conducted. To bring another contractor up to speed would be a very inefficient and arduous task.

The infrastructure for these activities has already been built by the contractor Theradex. It would be less efficient and more costly to transition these activities to another contractor at this juncture.

the NCI Clinical Trials infrastructure and technical expertise in utilizing and building studies in the CDMS software Medidata Rave make them uniquely qualif ied to provide the needed services. It would take months of Program time to bring a new contractor up to speed on this projects and additional months to build and implement electronic case report forms and the IT infrastructure to support these studies.

It would be impractical for a separate contractor to be brought on for the work related to these ongoing activities as the current contractor has been involved in these activities since their inception. For this work to be provided by anyone other than Theradex would necessitate the duplication of the following efforts already incurred during the existing contract: 1) Rebuild the studies in MediData Rave;

there would be duplication of effort if the data has to be transferred to another vendor. The NCCAPS COVID-19 study required customized forms since it is not a typical cancer treatment study for which standard electronic case report forms are available and could be re-purposed. The estimated time for building the forms is 4-6 weeks and an estimated labor hours. 2) Data management activities including data queries are currently ongoing for both the COVID-19 protocols and Moonshot. A separate contractor would require at least a 3-month phase-in period as well as time to get a Federal Information Security Management Act Authorization To Operate (FISMA ATO) before they can be up and running. A FISMA ATO can take up to 6 months. This would have a substantial adverse impact on the continuity of the ongoing clinical studies, patient enrollment and clinical data management and monitoring activities.

Adding work to the current contract to include additional level-of-effort to continue the aforementioned activities will ensure a seamless f low of work with no negative impact to meeting the goals of the ongoing

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a beta.SAM.gov notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Sources Sought Notice was posted on beta.sam.gov for 15 days from March 10, 2021 to March 25, 2021. This notice described the work being sought by NCI and requested capability statements from potential sources. One capability statement was received in connection with the posting of this notice. The capability statement was reviewed by the COR and was found to be unacceptable. The offeror did not provide an adequate response with respect to their experience, expertise, and technical approach to perform the requirements notes in the Sources Sought Notice.

A Pre-Solicitation Notice was published on beta.Sam.gov on March 30, 2021 and closed on April 14, 2021. One capability statement was received as a result of this notice. The capability statement was reviewed by the COR and found to be unacceptable. The offeror did not provide an adequate response with respect to addressing the project needs, demonstrating their experience and expertise, and ability to perform the tasks stated within the Pre-Solicitation Notice.

A Justification and Approval notice will be posted on beta.Sam.gov within 14 days of a contract action being executed and the results of this market research were sent to the Small Business Office (SBO)for concurrence on 4/21/2021. SBO concurrence was received on 4/23/2021.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

An Independent Government Cost Estimate (IGCE) was developed using historical data on costs incurred on the current, active contract with Theradex as associates and clinical operations personnel.

The Contracting Officer will obtain certified cost and pricing data as necessary to establish a fair and reasonable price for the services being acquired, if required by FAR 15.403-4. After receipt of a cost proposal for this work, if FAR 15.403-4 does not require certified cost and pricing data (e.g., if the dollar threshold for certified cost and pricing data is not met), the Contracting officer will require Data Other Than Certif ied Cost or Pricing Data to support proposed costs. The Contracting Officer will conduct a cost analysis and cost realism analysis as part of the award decision. The cost analysis will include comparing separate, individual cost elements in the proposal to costs incurred on the current, active contract, which was the result of adequate price competition.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The following market research efforts were conducted:

Published formal Sources Sought Notice in the Government-wide Point of Entry. The notice was published on March 10, 2021 with a response date of March 25, 2021. One capability statement was received in response to the notice. The COR reviewed the capability statement and found it to be unacceptable. The offeror did not address how the requirements of the work scope will be met. The capability statement did not include any corporate experience as a Clinical Research Organization running, monitoring, or managing clinical trials. While some IT experience was mentioned in the Capabilities Statement, experience was not in the area of integration of biomarker data with clinical data. No relevant experience related to management of clinical trial data other than laboratory testing was included in the capability statement. Overall, the capability statement merely restated the information in the sources sought notice, without expertise, and technical approach as it relates to the scope of work.

In addition to the Source Sought notice, a Pre-Solicitation Notice was Published on March 30, 2021 with a response date of April 14, 2021.

One capability statement was received in response to the notice. The COR reviewed the capability statement and found it to be unacceptable.

The offeror did not address how the work scope requirements would be met. The capability statement did not provide sufficient details to demonstrate the organization is capable of performing and completing the work. While the offeror did mention some IT experience, the experience is not specific to the integration of biomarker data with clinical data. The offeror did not provide or demonstrate experience functioning as a Coordinating Center or Data Management Center for a clinical study, Medidata Rave, or other comparable EDC systems. In summary, the capability statement failed to demonstrate the offeror possessed the experience, expertise and technical ability to perform the work stated within the notice.

Reviewed responses to original contract solicitation for similar capability.

No capable vendor was found.

Contacted knowledgeable individuals in Government regarding market capabilities to meet requirements.

Queried Government-wide databases and other commercial databases for information relevant to the acquisition.