Sample_Task_Order__4_REV_12-21-15.pdf

SAMPLE TASK ORDER REQUEST FOR PROPOSAL #4

NOTE: THIS IS ONLY A SAMPLE - NO TASK ORDER AWARD WILL BE MADE IN RESPONSE TO THIS

REQUEST

Contractor: _________TBD_____________

Contract No: ________TBD _____________

TORP No: _ 4__ Modification No: _____

Order Title: Clinical Pharmacology Support for an NCI Phase I Trial of NSC XXXXX

Task Order Type: Fixed Price (FP)

Order Originator: ____ _________________ Date Prepared: __________________________

Part I. INITIATOR’S REQUEST

A. Period of Performance: TO BE DETERMINED

B. Statement of Work/Protocol/Project Description:

The purpose of this Task Order (TO) is to provide a resource for analytical and pharmacokinetic support to an NCI Phase I clinical trial with NSC XXXXX:

Phase I Trial of NSC XXXXX in Adults with Refractory Solid Tumors

The following specific elements are included:

Implement appropriately validated LC-MS/MS methodology for the quantification of NSC XXXXX in human plasma and urine.

Secure all needed internal approval(s) for receipt and analysis of human samples to be generated by this NCI Phase I trial. The clinical protocol and certification of NCI IRB approval will be provided to you.

Determine levels of NSC XXXXX in human plasma and urine samples obtained from up to 30 patients in the clinical trial. It is anticipated that 12 plasma and 3 urine samples will be collected from each patient in cycle 1 only (= 360 plasma samples and 90 urine samples).

Samples sets will be shipped as patients are accrued and treated, so planning for intermittent analyses will be critical. For costing purposes, assume samples will be analyzed in five (5) batches.

Pharmacokinetic data analysis shall include standard non-compartmental modeling to determine Cmax, Tmax, AUC0∞

, AUClast, CL, and t½, Vss, for each patient. Cumulative urinary excretion and clearance shall also be determined. Population modeling approaches may be also proposed.

C. Deliverables:

Interim c vs. t data for each patient to be sent to the COR within 14 working days after receipt of samples. Preliminary PK parameter estimates after one additional week.

hudakad Typewritten Text RFP Number: N02CM67000-11 hudakad Typewritten Text Attachment 19-4

Draft bioanalytical and clinical pharmacokinetics report due one month after analysis of the final patient sample set. The final report will be due 14 working days after return of the draft report for revision.

D. Additional Instructions:

As Task Orders may be competed among the contractors if multiple awards are made pursuant to this RFP, please consider and provide information in your response to address Items E and F.

E. Evaluation Factors:

Proposals will be evaluated on the following factors, in order of importance:

1) Technical (Weight 40%): Prior experience in implementing and utilizing validated analytical methods for compounds being evaluated in early clinical trials. Experience with pharmacokinetic modeling of concentration-time data in a clinical pharmacology setting. Familiarity with compartmental and population modeling is a plus.

2) Schedule (Weight 30%): Demonstrated ability to rapidly perform sample analysis to assure timely delivery of tabulated data within 14 working days from the time of sample receipt. Ability to expeditiously handle intermittent sample shipments, with the possibility of periods with no work.

3) Cost (Weight 30%): Ranking of overall costs and cost per sample.

F. Order Response:

G. Technical Proposal shall be 3-4 pages in length and consist of a brief summary of your approach to analytical method implementation, the schedule for sample analysis as batches are received, and the relevant experience with similar tasks and timelines.

The Business Response shall at least include a coversheet and a budget (provided substantially as indicated in Part II of this form). The Coversheet shall at least consist of:

• RFP Number

• Task Order RFP Number

• Name, address, email and telephone number of point of contact

• Name, address, email and telephone number of contract Administration Office (if applicable)

• Date of submission

• Name, title, address, email, telephone and signature of authorized Business Representative

(person authorized to sign contracts on behalf of the organization).

There are no Options associated with this Task Order

H. Order Response Due Date: Responses to this Task Order shall be included in your technical and business proposals for this RFP.

TASK ORDER REQUEST FOR PROPOSAL (TORP)

Contractor: _____________[fill in]____________________ Contract No: ___ __________________

TORFP No: __4 ___ Modification No: __ 0____ Date Prepared: ______________________

Part II. CONTRACTOR’s RESPONSE TO ORDER REQUEST (*The Contractor shall attach a detailed budget to this form to identify all proposed fixed- price costs.)

A. Estimated Cost and Effort:

1. Labor hours – list order leader, specific individuals to be assigned, labor category, and estimated hours for each.

2. Labor costs – list by labor category and total.

3. Employee benefits.

4. Direct materials.

5. Travel.

6. Subcontracts.

7. Other direct costs.

8. Indirect costs.

9. Total estimated costs for this Order: ______________*

B. Detailed description of the approach to be used and of the deliverable(s). (Be specific):

APPROVAL TO PROCEED: The Contractor shall not exceed the estimated labor hours, estimated Order amount, or change the Order leader without the prior written approval of the Contracting Officer’s Representative and the Contracting Officer.

1. For the Contractor: _____________________________ Date: __________________

(Signature)

Typed Name: __________________________________

2. For the Government: ____________________________ Date: __________________ Contracting Officer’s Representative (COR)

____________________________ Date: __________________ Contracting Officer