1-SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Access to the Florence electronic Trial Master File (eTMF) Platform

Statement of Need and Purpose:

The NCATS’ Rare Disease Clinical Research Network (RDCRN) needs a vendor to Provide an eTMF platform. Access to this platform should be enabled via single sign on (SSO).

Background Information and Objective:

The SiteLink subscription includes a dedicated digital space for regulatory and source document collection and management per active investigator site for each study contracted under the Agreement, and allows site and Customer access to all currently available Florence features and any updates or upgrades during the term of the Agreement for all Authorized Users, as well as unlimited document storage and users for all studies for the research sites in Customer’s studies. The use of eSignatures by sites is permitted in the SiteLink subscription.

Work Instructions. Florence will develop and provide Customer with work instructions on key workflows for Customer process validation and as a training reference.

Standard Operating Procedures. Florence will deliver SOP templates and best practices and assist in modifying Customer’s existing SOPs.

Validation.

Florence will provide a sample template with suggested test cases for system validation.

It is Customer’s responsibility to complete validation testing requirements as defined by their organizational policies.

Florence will provide a document for Customer to record validation of the Florence platform’s compliance with 21 CFR Part 11 requirements.

Customer Training.

Florence will provide a live training session for Customer, via Zoom or a similar platform, that will be recorded for future use by Customer. This session will focus on the use and administration of Florence Products and Services. Additional training will be made available via online modules on the Florence Learning Management System.

Access. Access will be provided for bugs and feature request submission, and to online training and knowledge base.

eTMF Description eTMF + eBinders™ Subscription. The eTMF subscription includes all currently available features and any updates or upgrades during the term of the Agreement for all Authorized Users, as well as unlimited document storage and users for all studies. The eBinders subscription includes a dedicated site space per site per study and site access to all currently available eTMF features and any updates or upgrades for all Authorized Users, as well as unlimited document storage and users for all studies. Even if a site does not access eBinders, Customer will pay for any site participating in a given study. Customer is responsible for duplicating any site document into the appropriate eTMF. Source data verification (SDV) and PHI folders are included, if desired. Training is administered via online modules in the Florence Learning Management System. The use of eSignatures by the site is permitted under the eBinders subscription.

Documentation. The subscription described herein includes Customer’s use, for its internal business purposes only, of all externally available documentation with respect to security and validation documentation, SOPs, user guides, and the eBinders Knowledge Base.

Configuration. All implementation configuration, SOP consulting, training, and support levels are as described in the applicable Exhibit or Statement of Work.

Training.

For sponsor and site users: standardized training via the Florence Learning Management System.

Certification for sponsor super-users via the Florence Learning Management System.

Period of Performance:

12 Months Annual Subscription ARO

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

eTMF and SiteLink® Implementation (for eBinders™ and Remote Monitoring) eTMF and SiteLink will be made available to new and existing studies, at Customer’s discretion, with the following deliverables.

● Remote Kickoff. Planned kickoff within 4 weeks of the Effective Date of the Agreement.

● UAT and Production Activation. Customer may have immediate access to the UAT environment and access to the production environment upon completion of implementation. The UAT environment may be hosted solely in the US or also in other data center locations, in Florence's discretion.

● Teams. One UAT Team and one eTMF Production Team.

● Roles and Access. The Florence Implementation team will provide up to five (5) hours of consulting to guide Customer on creating and provisioning access to project managers, site staff members, PIs, executives, and monitors.

● Standard Operating Procedures. Florence will provide consulting to deliver SOP templates and SOP best practices and provide feedback on Customer’s SOPs.

● Timing. Implementation and consulting services must be used within twelve (12) weeks after the completion of the remote kickoff.

● Additional Resources. Additional implementation resources are available at Florence’s then current hourly rates.

● Work Instructions. Work instructions will be developed for Customer process validation and as a training reference.

eTMF Implementation Training (One-Time) At no additional cost to Customer, Florence will provide access to online training modules via the Florence Learning Management System. Optional additional training may be available.

Site Activation and Training Site activation is the process by which a digital site space with preconfigured binders and user roles is created for each site, training is administered, and site personnel access is granted.

● Activation. New studies and sites are submitted to Florence in the portal. Upon submission, Florence will create new site eBinders Team spaces within ten (10) business days and invite site admin users to complete training.

● Training. Site training and eBinders™ Team activation is handled wholly by the Florence team in accordance with the configuration and SOPs established during implementation.

Training will be administered via online modules in the Florence Learning Management System. Management of training documentation is Customer’s responsibility.

LEVEL OF EFFORT:

Ongoing:

● Basic support provides ten (10) hours per year of email, chat, and phone support.

Support hours are 24x7 for phone and Sunday 6 PM through Friday 7 PM U.S. Eastern time for email and chat.

● Response within one business day.

● Issue tracker access for bugs and feature requests.

● Training through the Vendor Learning Management System and knowledge base.

● Additional Support Packages o Silver: Thirty (30) support hours per year for $7,500 annually.

o Gold: Sixty (60) support hours per year for $13,500 annually.

o Hourly: 10-hour blocks, at $3,000 per block.

● Every other month support calls led by Customer Success Management.

● Executive Business Reviews: Up to two times per year.

GOVERNMENT RESPONSIBILITIES

NCATS will be responsible for:

● Providing test account metadata and user email domain to vendor for configuration and testing. Vendor development work will begin after this step is completed by NCATS.

● NCATS to add Vendor metadata to our identity provider server and add Vendor domains to whitelist.

● Performing user acceptance testing with test cases provided by Vendor.

● Providing information about future updates to SSO account to Vendor with minimum two

(2) weeks’ notice before configuration changes are required.

DELIVERY OR DELIVERABLES

Single Sign On Integration with Florence RDCRN Platform

REPORTING REQUIREMENTS

All Reports should be delivered to Sam Michael at michaelsg@mail.nih.gov

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Roles and Responsibilities

Role Responsibility

Account Representative Account Rep will coordinate activities between Florence and Customer related to this SOW.

Project Manager Project Manager will coordinate the Florence deployment, training and project manage the process.

Account Manager

Account Manager will serve as primary Florence point of contact following deployment providing reviews and will handle any questions that arise following the end of deployment.

Technical Lead Technical Lead is responsible for overseeing the delivery and ongoing support of the Products.

2. Customer Roles and Responsibilities

Role Responsibility

Project Manager Project Manager is responsible for coordinating Customer resources and personnel and will be point of contact for deliverables.

Technical Lead IT Technical Lead is responsible for coordinating personnel required for IT work in scope.

Regulatory Admin/Lead Regulatory Admin/Lead will be responsible for decision making on SOPs, workflows etc.

Information System Security Plan:

Data Rights:

Section 508—Electronic and Information Technology Standards:

N/A

Publications and Publicity:

N/A

Confidentiality of Information:

1.