NCI Draft Statement of Work.pdf

STATEMENT OF NEED (SON)

1.0 TITLE

Procurement of Brand-Name TrialTrove Licenses for Access to Database with Clinical Trail

Information

2.0 BACKGROUND

Throughout the last few decades, cohort-based observational studies have helped researchers to better understand the complex etiology of cancer, and have provided fundamental insights into key environmental, lifestyle, clinical, and genetic determinants of this disease and its outcomes.

More recently, the onset of the “‘omics age” and precision medicine has compelled many research organizations to encourage collaborations across existing large cohorts. Such a collaborative approach enables the development of studies large enough to address the dynamic and interactive nature of the factors underlying common diseases. Since cohorts represent the cornerstone of the continuum from discovery to practice, this approach expedites translation by integrating data collected through the lifespan, in health and disease status, and provides a large framework for interdisciplinary research.

The Cancer and Data Science Laboratory (CDSL) was formed in early 2018 with the mission of developing and harnessing a broad spectrum of computational approaches for analyzing and integrating cancer omics laboratory and patient data. The CDSL develops new, cutting-edge computational approaches and algorithms to this end, addressing fundamental research questions concerning cancer origin, evolution, progression and treatment, serving the cancer community at large. The lab works in a highly collaborative and integrative manner with other research labs within the Center for Cancer Research (CCR) to provide an analysis counterpart to their experiments and generate further testable predictions whose experimental outcomes could further feedback to the computations.

While there are tools and databases available (such as the NCI sponsored Cancer Epidemiology

Descriptive Cohort Database (CEDCD) (Phase I)) for facilitating the identification of cancer epidemiology cohorts, the CDSL requires additional clinical trials datapoints than are captured in databases selectively inclusive of cohort-based observational studies. The CDSL requires access to a database which do not have the same limitations as systems focused solely on data from the

CEDCD-supported and collaborating cohorts. This database will facilitate the development of collaborative projects, accelerate research, and expand access.

3.0 SCOPE

The Contractor shall provide licenses for end-user access to a clinical trials database that links data from reported clinical trials for studies around the world.

3.1 CONTRACT LINE ITEMS

Contract

Line Item

Number

(CLIN)

Description Contract

Period

Unit Unit

Price

Quantity Price

1 Multi-User

License Seat for Online

Database

Base

Period

User

Seat

$9,450.00 2 TBD

101 Multi-User

License Seat for Online

Database

Option

Period 1

User

Seat

$9,450.00 2 TBD

4.0 SPECIAL ORDER REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

Licenses provided as part of this Order must provide access to a database which meets the salient characteristics described in this section:

• This database must include a user interface that enables users to bulk download information for thousands of trails for each download.

• Database must be updated no less than once every business day. Database must include data on trial benchmarks and metrics, patient populations, endpoints, outcomes, geographic distribution, enrollment and study timelines, and other relevant data for included clinical trials.

• User interface must allow for end-users to create customized dashboards and filter results to facilitate end-users’ ability to identify relevant results.

• Must allow end-users to export full data in a way that can be “frozen”, so that large-scale data science analysis can be done over an extended period with reference to one snapshot of all the data. The download should be in a searchable format compatible with MS Excel.

• Databases must support identification of biomarker data and a robust range of trial result fields. Database must include cross-references to the original sources from which the data in the database were curated.

4.2 USER AND TECHNICAL SUPPORT

The Contractor shall provide technical support, maintenance, and end-user support for the database throughout the Period of Performance of this Order. Support and maintenance shall include:

• End-user support via online ticket, e-mail, and/or telephone with commercially reasonable response times.

• Support for scientific questions about the data including the correspondence between original peer-reviewed publications and the curated data in the database.

• Platform that allows end-users to submit debugging requests.

• Access to any online training or troubleshooting materials related to the platform (e.g.

webguides, webinars).

• Product release announcements, product lifecycle announcements, and key feature updates provided via e-mail.

• Major version upgrade and patches provided at no additional cost to the Government and implemented in accordance with the Contractor’s standard commercial procedures.

Telephone and/or chat support shall be available during normal business hours, defined as Monday –

Friday, 8:00 AM – 4:00 PM Eastern Time.

4.3 DELIVERY / INSTALLATION

The Contractor shall furnish all licenses within one (1) business day of the effective date of the award. Contractor shall provide any relevant log-in instructions and technical support to facilitate end-user registration and access.

All deliverables shall be furnished to the Technical Point of Contact (TPOC) and the alternate

Technical Point of Contact (ATPOC) listed below:

TBD at Award

4.4 TRAINING

The Contractor shall provide training within 10 business days after activation of licenses, unless otherwise directed by the TPOC or the Contracting Officer (CO). Training shall be provided live virtually.

The Contractor shall provide end-users with access to any and all training resources (e.g. pre-recorded webinars, user guides).

4.5 ADVANCED UNDERSTANDINGS

The NCI will utilize data obtained from this database to conduct research and to publish research papers and other scientific publications. The Contractor grants the NCI an irrevocable license to publish derived analyses with summary data based on individual-level trial database.

5.0 TYPE OF ORDER

This is a Firm Fixed Price Purchase Order (PO) for electronic information technology (EIT) licenses

5.1 SEVERABLE SERVICES

The services delivered by the Contractor under this PO are severable services. Funds are only available for use for the contract line item number (CLIN) for which they are obligated. Unused funds from one PO period or CLIN may not be used for or “roll over” to other PO periods or CLINs.

6.0 PERIOD OF PERFORMANCE

The Period of Performance shall be for one (1) 12-month Base Period and one (1) 12-month Option

Period beginning from the Effective Date of the Purchase Order.

7.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described to be delivered under this Purchase Order is subject to final inspection and acceptance by an authorized representative of the Government. All services delivered to the authorized representative of the Government will be deemed to have been accepted 30 calendar days after date of delivery, except as otherwise specified in this Order if written approval or disapproval has not been given within such period. The Government’s approval or revision to the services delivered shall be within the general scope of work stated in this Order.