MAS - Certara USA Inc. - GS35F095CA

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Attached to
Federal Supply Schedule GS35F095CA Federal contract IDV
Contract number
GS35F095CA
Issued by
GSA Federal Acquisition Service

About this file

Products and Services:

  • Information Technology and Professional Services
  • Electronic Commerce and Subscription Services
  • Labor Categories/Proposed Services:
    • Solutions Architect: Design software solutions and lead a project team in delivering the detailed design. Provide high-level consulting expertise across projects or project teams.
    • Software Developer: Analyze and study complex system requirements. Design software tools and subsystems to support software reuse and domain analyses and manages their implementation.
    • Business Analyst: Expertise in business process analyses. requirements definition, skills assessments, gap analyses, business management and process documentation/mapping, knowledge management process, strategy, and implementation.
    • CDISC SME/Lead: Participate in the creation and management of therapeutic and project level standards aligned with CDISC SDTM, ADaM, and SEND standards.
    • Data Fitness Analyst: Perform analysis of study data to evaluate CDISC compliance and data fitness (quality and reviewability), determining the impact on the review process.
  • Products:
    • OpenCDISC Enterprise Tier 0: Annual Maintenance and Support, includes software updates, patches, bug fixes, and technical support, period: 12 MONTHS, hours of technical support: UNLIMITED, number of studies allowed: 20
    • OpenCDISC Enterprise Tier 1: Annual Maintenance and Support, includes software updates, patches, bug fixes, and technical support, period: 12 MONTHS, hours of technical support: UNLIMITED, number of studies allowed: UNLIMITED

Location:

  • The Geographic Scope of Contract will be domestic delivery only.
  • Point(s) of Production: BLUE BELL, PA

Dates:

  • Contract Period: 11-29-2019 through 11-30-2024.

People:

  • Company: PINNACLE 21, LLC
  • Contract Administrator: Max Kanevsky, Founder & CEO
  • Contact Information: 267-331-4431, max@pinnacle21.com
  • Business Size: Small
  • DUNS: 078853060
  • UEI: VB5LDF5AU489
  • Website: http://www.pinnacle21.com

Pinnacle 21, LLC Pricelist and/or Vendor Terms and Conditions for GS35F095CA, a Federal Supply Schedule awarded to Pinnacle 21, LLC, under Information Technology Schedule 70 (IT-70)

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AUTHORIZED FEDERAL ACQUISITION SERVICE

INFORMATION TECHNOLOGY SCHEDULE PRICE LIST

GENERAL PURPOSE COMMERCIAL INFORMATION TECHNOLOGY

EQUIPMENT, SOFTWARE, AND SERVICES

54151S Information Technology Professional Services

FPDS Code D301 ............................ IT Facility Operation and Maintenance FPDS Code D302 ............................ IT Systems Development Services FPDS Code D306 ............................ IT Systems Analysis Services FPDS Code D307 ............................ Automated Information Systems Design and Integration Services

FPDS Code D308 ............................ Programming Services FPDS Code D310 ............................ IT Backup and Security Services FPDS Code D311 ............................ IT Data Conversion Services FPDS Code D313 ............................ Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) Services FPDS Code D316 ............................ IT Network Management Services FPDS Code D317 ............................ Creation/Retrieval of IT Related Automated News Services, Data Services, or Other Information Services (All other information services belong under Schedule 76) FPDS Code D399 ............................ Other Information Technology Services, Not Elsewhere Classified

54151ECOM Electronic Commerce and Subscription Services

FPDS Code D399 Other Data Transmission Services, Not Elsewhere Classified

PINNACLE 21, LLC

1777 SENTRY PKWY W STE 405

BLUE BELL, PA, 19422-2224

Office: 267-331-4431 Email: max@pinnacle21.com

Fax: 888-507-2270 Contract Number: GS-35F-095CA

Period Covered by Contract:11 30-2024 through 11-30-2029.

Modification No. PS-0039 as of August 4, 2025

General Services Administration Federal Acquisition Service

Products and ordering information in this Authorized Information Technology Schedule Pricelist are also available on the GSA Advantage! System (http://www.gsaadvantage.gov).

mailto:max@pinnacle21.com http://www.gsaadvantage.gov/

CUSTOMER INFORMATION:

1a. TABLE OF AWARDED SPECIAL ITEM NUMBERS (SINs) AWARDED PRICES

54151S Information Technology and Professional Services Page 2 - 3

54151ECOM Electronic Commerce and Subscription Services

1b. LOWEST PRICED NUMBER AND PRICE FOR EACH SIN:

(Government net price based on a unit price)

SIN# Labor Category/ Proposed Service

UOI

54151S Software Developer Hourly

54151ECOM OpenCDISC Enterprise Tier 0

N/A

1c. SIN54151S INFORMATION TECHNOLOGY PROFESSIONAL SERVICES &

SIN54151ECOM ELECTRONIC COMMERCE AND SUBSCRIPTION

Labor Category

Minimum / General Experience and Years of Experience

Functional Responsibility Education Requirements

Solutions Architect

7 Design software solutions and lead a project team in delivering the detailed design. Provide high-level consulting expertise across projects or project teams. Work with customers to strategize new business models and solutions. Convert high-level user requirements into a deliverable design specification, define component architectures, and assist in task estimates and project scope. Select tools and products to facilitate the implementation of the architecture.

Degree in Computer Science, Information Systems and or related field required. Must have demonstrated strong team leadership and project management, strong communication skills, domain knowledge of key business functions.

BS/MS

Category

Minimum / General Experience and Years of Experience

Functional Responsibility Education Requirements

Software Developer

3 Analyze and study complex system requirements. Design software tools and subsystems to support software reuse and domain analyses and manages their implementation. Estimate software development costs and schedule.

Review existing programs and assist in making refinements, reducing operating time, and improving current techniques.

Degree in Computer Science and or related field. Must be well versed in Java, SQL, HTML, JavaScript, and XML.

BS

Business Analyst

3 Expertise in business process analyses.

requirements definition, skills assessments, gap analyses, business management and process documentation/mapping, knowledge management process, strategy, and implementation. Degree in Information Systems and or related field.

BA/BS/MS

CDISC

Subject Matter Expert

(SME)

/Lead

7 Participate in the creation and management of therapeutic and project level standards aligned with CDISC SDTM, ADaM, and SEND standards.

Act as an expert on CDISC standards and submission requirements. Facilitate effective communication and collaboration between data standards group and reviewer teams, including statisticians, statistical programmers, and medical reviewers. Author and review SOPs and procedures for use of clinical data standards in the regulatory review process. Degree in a Health Science, Biostatistics, Computer Science or related discipline with professional experience in a pharmaceutical, CRO, or consulting setting.

BS/MS

Category

Minimum / General Experience and Years of Experience

Functional Responsibility Education Requirements

Data Fitness Analyst

5 Perform analysis of study data to evaluate CDISC compliance and data fitness (quality and reviewability), determining the impact on the review process. Assess submission data structure and adequacy of the reviewer's guide. Perform additional data exploration to identify data quality and traceability issues. Produce outputs from all data fitness tools, documenting and communicating findings to the review team. Prepares information and data to support the reviewer's communication

BS

with the sponsor. Degree in a Health Science, Biostatistics, Computer Science or related discipline with professional experience in a pharmaceutical, CRO, or consulting setting. Expert knowledge of OpenCDISC Enterprise platform, CDISC standards, and regulatory review process.

SIN54151ECOM ELECTRONIC COMMERCE AND SUBSCRIPTION

MFR PART

NO.

PRODUCT

NAME

PRODUCT DESCRIPTION

WARRANTY

OCE-TIER-

OpenCDISC Enterprise Tier 0

Annual Maintenance and Support

- includes software updates, patches, bug fixes, and technical support -

- period: 12 MONTHS -

- hours of technical support:

UNLIMITED

- number of studies allowed: 20

Standard Commercial

OpenCDISC Enterprise Tier 1

Annual Maintenance and Support

- includes software updates, patches, bug fixes, and technical support -

- period: 12 MONTHS -

- hours of technical support:

UNLIMITED

- number of studies allowed:

UNLIMITED

2. MAXIMUM ORDER:

(All dollar amounts are exclusive of any discount for prompt payment.)

The Maximum Order for the following Special Item Numbers (SINs) is $500,000:

Special Item Number 54151S – Information Technology Professional Services Special Item Number 54151ECOM – Electronic & Commerce Subscription Services

NOTE TO ORDERING ACTIVITIES: *If the best value selection places your order over the Maximum Order identified in this catalog/pricelist, you have an opportunity to obtain a better schedule contract price. Before placing your order, contact the aforementioned contactor for a better price. The contractor may (1) offer a new price for this requirement

(2) offer the lowest price available under this contract or (3) decline the order. A delivery order that exceeds the maximum order may be placed under the schedule contract in accordance with FAR 8.404.

3. MINIMUM ORDER: $100

4. GEOGRAPHIC COVERAGE: The Geographic Scope of Contract will be domestic delivery only.

5. POINT(S) OF PRODUCTION: BLUE BELL, PA

6. DISCOUNT FROM LIST PRICES: Discount reflected in GSA proposed price with

IFF.

7. QUANTITY DISCOUNT(S): None

8. PROMPT PAYMENT TERMS: 1%, NET 15 days

9a. Government Purchase Cards are accepted at the micro-purchase threshold.

9b. Government Purchase Cards are accepted above the micro-purchase threshold. Contact contractor for limit.

10. FOREIGN ITEMS: Not Applicable

11a. TIME OF DELIVERY: As agreed between ordering agency and contractor

11b. EXPEDITED DELIVERY: Not Applicable

11c. OVERNIGHT AND 2-DAY DELIVERY: Not Applicable

11d. URGENT REQUIRMENTS: Agencies can contact the Contractor’s representative to affect a faster delivery. Customers are encouraged to contact the contractor for the purpose of requesting accelerated delivery.

12. FOB POINT: Destination

13a. ORDERING ADDRESS: Same as contractor

13b. ORDERING PROCEDURES: Ordering activities shall use the ordering procedures described in Federal Acquisition Regulation 8.405-3 when placing an order or establishing a BPA for supplies or services. The ordering procedures, information on Blanket Purchase Agreements (BPA’s) and a sample BPA can be found at the GSA/FSS Schedule Homepage (fss.gsa.gov/schedules).

14. PAYMENT ADDRESS: Same as contractor

15. WARRANTY PROVISION: N/A, Services Only

16. EXPORT PACKING CHARGES: Not Applicable

17. TERMS AND CONDITIONS OF GOVERNMENT PURCHASE CARD

ACCEPTANCE: (Any thresholds above the micro-purchase level may be inserted by contractor)

18. TERMS AND CONDITIONS OF RENTAL, MAINTENANCE, AND REPAIR (IF

APPLICABLE): Not Applicable

19. TERMS AND CONDITIONS OF INSTALLATION (IF APPLICABLE): Not Applicable

20. TERMS AND CONDITIONS OF REPAIR PARTS INDICATING DATE OF PARTS

PRICE LISTS AND ANY DISCOUNTS FROM LIST PRICES (IF AVAILABLE): Not Applicable

20a. TERMS AND CONDITIONS FOR ANY OTHER SERVICES (IF APPLICABLE):

Not Applicable

21. LIST OF SERVICE AND DISTRIBUTION POINTS (IF APPLICABLE): Not Applicable

22. LIST OF PARTICIPATING DEALERS (IF APPLICABLE): Not Applicable

23. PREVENTIVE MAINTENANCE (IF APPLICABLE): Not Applicable

24a. SPECIAL ATTRIBUTES SUCH AS ENVIRONMENTAL ATTRIBUTES (e.g.

recycled content, energy efficiency, and/or reduced pollutants): Not Applicable

24b. Section 508 Compliance for Electronic and Information Technology (EIT):

http://www.pinnacle21.net

25 DUNS NUMBER: 078853060

26. NOTIFICATION REGARDING REGISTRATION IN SYSTEM FOR AWARD

MANAGEMENT (SAM) DATABASE: Contractor has an Active Registration in the SAM database.

http://www.pinnacle21.net/

54151S IT Professional Services Labor Category Descriptions

Solutions Architect

Design software solutions and lead a project team in delivering the detailed design. Provide high-level consulting expertise across projects or project teams. Work with customers to strategize new business models and solutions. Convert high-level user requirements into a deliverable design specification, define component architectures, and assist in task estimates and project scope. Select tools and products to facilitate the implementation of the architecture.

BS/MS in Computer Science, Information Systems, or related discipline with 7+ years of relevant experience. Must have demonstrated strong team leadership and project management, strong communication skills, domain knowledge of key business functions.

Software Developer/Engineer

Analyze and study complex system requirements. Design software tools and subsystems to support software reuse and domain analyses and manages their implementation. Estimate software development costs and schedule. Review existing programs and assist in making refinements, reducing operating time, and improving current techniques.

BS in Computer Science or related discipline with 3+ years of relevant experience. Must be well versed in Java, SQL, HTML, JavaScript, and XML.

Business Analyst

Expertise in business process analyses. requirements definition, skills assessments, gap analyses, business management and process documentation/mapping, knowledge management process, strategy, and implementation.

BA/BS/MS in Information Systems or related discipline with 3+ years of relevant experience.

CDISC SME/Lead

Participate in the creation and management of therapeutic and project level standards aligned with CDISC SDTM, ADaM, and SEND standards. Act as an expert on CDISC standards and submission requirements. Facilitate effective communication and collaboration between data standards group and reviewer teams, including statisticians, statistical programmers, and medical reviewers. Author and review SOPs and procedures for use of clinical data standards in the regulatory review process.

BS/MS in a Health Science, Biostatistics, Computer Science or related discipline with 7+ years of relevant experience in a pharmaceutical, CRO, or consulting setting.

Data Fitness Analyst

Perform analysis of study data to evaluate CDISC compliance and data fitness (quality and reviewability), determining the impact on the review process. Assess submission data structure and adequacy of the reviewer's guide. Perform additional data exploration to identify data quality and traceability issues.

Produce outputs from all data fitness tools, documenting and communicating findings to the review team.

Prepares information and data to support the reviewer's communication with the sponsor.

BS in a Health Science, Biostatistics, Computer Science or related discipline with 5+ years of relevant experience in a pharmaceutical, CRO, or consulting setting. Expert knowledge of OpenCDISC Enterprise platform, CDISC standards, and regulatory review process.

54151ECOM Electronic & Commerce Subscription Services

MFR PART

NO.

PRODUCT

NAME

PRODUCT DESCRIPTION

WARRANTY

OpenCDISC Enterprise Tier 0

Annual Maintenance and Support

- includes software updates, patches, bug fixes, and technical support -

- period: 12 MONTHS -

- hours of technical support:

UNLIMITED

- number of studies allowed: 20

Standard Commercial

OCE-TIER-

OpenCDISC Enterprise Tier 1

Annual Maintenance and Support

- includes software updates, patches, bug fixes, and technical support -

- period: 12 MONTHS -

- hours of technical support:

UNLIMITED

- number of studies allowed:

UNLIMITED

File details come from the government source that posted it. Updated .