MODIFICATION
70 -- Clinical Trials Management System
- Notice Date
- 2/8/2013
- Notice Type
- Modification/Amendment
- NAICS
- 541513
— Computer Facilities Management Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-13-R-0022
- Response Due
- 2/19/2013
- Archive Date
- 4/9/2013
- Point of Contact
- Dana Kavitski, 301-619-8987
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(dana.kavitski@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Amendment 0003 to Solicitation W81XWH-13-R-0022 is to answer offerors' questions and make the changes set forth below. Attachment 4: 52.212-2, Evaluation -- Commercial Items is revised to add information regarding Contractor Administrative Support and Past Performance Relevancy Ratings. The revised version is attached to this Amendment. Attachment 5: Proposal Submission is also revised to identify it as an addendum to FAR Provision 52.212-1 and correct a formatting error (see Question 23). The revised version is attached to this Amendment. This Amendment also corrects CLIN 6001. CLIN 6001 shall be priced as follows: quote mark CLIN 6001: $ ______________ QTY 1 Each - Contractor Manpower Reporting. ANNUAL Contractor Manpower Reporting. This report is due in October of each year. quote mark Far Clause 52.217-9 - Option to Extend the Term of the Contract is hereby included. The Government may extend the term of this contract by written notice to the Contractor within 30 days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension. If the Government exercises this option, the extended contract shall be considered to include this option clause. The total duration of this contract, including the exercise of any options under this clause, shall not exceed 57 months. See Amendment 0001 for Q1 and Amendment 0002 for Q3 - Q8. Q9: We want to reply to the CTMS RFP and we are beginning the process of obtaining a Certificate of Networthiness. Do you require that the certificate be obtained prior to replying to the RFP? We understand that the process of obtaining the certificate is a six to nine month process. This should allow for more than enough time to obtain the certificate before the CTMS is contracted for and we want to ensure that this is acceptable. A9: No, we do not require that the Certificate of Networthiness be obtained prior to replying to the RFP. Refer to Task 1 in the RFP base period, quote mark The contractor shall remediate network security vulnerabilities discovered during Certificate of Networthiness (CoN) testing in order to obtain a CoN. The contractor shall work collaboratively with USAMMDA staff to accomplish this task quote mark. Q10: The PWS states that the CSSD quote mark...performs FDA regulated sponsor representative responsibilities. quote mark Is it expected that the CTMS will be used for the development and approval of new drugs and devices, or for new indications for existing drugs and devices? A10: We Sponsor clinical trials for new drugs, biologics and devices, as well as clinical trials for new indications for approved drugs and devices. The CTMS will be used as a sponsor's clinical trial management tool. Q11: For quote mark Have the ability to build and track monitoring schedules, quote mark is CSSD interested in tracking the schedules of the monitoring personnel, the monitoring of tasks that need to be accomplished, both, or something else? A11: The statement quote mark Have the ability to build and track monitoring schedules quote mark refers to the scheduling of clinical monitoring visits by the sponsor's monitoring personnel. The monitoring of tasks that need to be accomplished would likely fall into the category of quote mark Track study milestones and supplies quote mark mentioned under performance characteristics in the PWS. Q12: For quote mark Generate, sign, and route required monitoring reports, quote mark is the routing expected to be within the system, externally via e-mail, or some other mechanism? A12: We would expect the routing to be external via email in order to route reports to study team members that do not have access to the CTMS. Q13: For quote mark Track study milestones and supplies, quote mark are milestones related to how many subjects have been recruited and procedures performed (as in non-military trials), or are there unique military milestones that need be tracked? A13: In addition to routine study milestones there may be some military milestones that we would like to track. For example, Army Human Research Protections continuing review dates, or Army Acquisition Decision Gate milestones. We would expect the milestones to be specific to each study. Q14: Also for quote mark Track study milestones and supplies, quote mark are supplies drugs and devices used in the trials, or something else? A14: Supplies refers to the supplies and products used in the clinical studies, which includes investigational products and devices used at the site. Q15: The Solicitation states that the license will be for 20 users. We assume that is for the 20 study coordinators. Do you anticipate the system being used by additional users at the sites to enter and collect data for the study including procedures, visits, completed case report forms, managing participants, etc.? Or is this strictly for the coordinators only who will enter the data? A15: This CTMS will be utilized at the IND sponsor level, not by a clinical site. The 20 users may include Clinical Trial Monitors, Clinical Trial Managers, Product Managers, Regulatory Affairs Scientists, CSSD leadership personnel, and administrative support. Q16: The solicitation states - Offerors must include a completed copy of the following provisions with their offer unless they are accessible in the Offeror's System for Award Management (SAM) profile. If any of the following provisions are not in the Offeror's SAM record, they must be completed and submitted with the offer or the offer may not be considered for award: 52.209-7 - Information Regarding Responsibility Matters 52.212-3, Offerors Representations and Certifications-Commercial Items (Alternate 1). 252.212-7000 Offeror Representations and Certifications--Commercial Items 252.225-7020 Trade Agreements Certificate Checking our company's SAM profile: a. We have completed 52.209-5, which seems to be the same as 52.209-7 indicated above. Is completing 52.209-5 sufficient for completing the 52.209-7 requirement, or do we need to submit 52.209-7 as well? b. If we must submit one of the above due to them are not available in the SAM profile, is it a acceptable to 'just' include them as a document as part of the proposal? A16: a. For consistency, 52.209-5 will not be sufficient to stand in place of 52.209-7. If 52.209-7 is not in your company's SAM record, please include it with proposal submission. b. If an offeror needs to submit a provision that is not included in its SAM record, the provision shall be submitted at the same time as the Phase I proposal in a separate document. Provisions submitted will not be counted towards the page limitations of the technical proposal. Q17: Throughout the Performance Work Statement and the Evaluation Factors for Award, these documents reference quote mark Monitoring activities. quote mark I wanted to see if we can get clarification on what is meant by Monitoring. Does this refer to the Monitoring of other Research Sites that are involved in a Study that the Army is coordinating, or does this refer to the necessary Monitoring activities that are involved with a Trial that the Army is conducting (i.e. subject accrual monitoring, subject visit monitoring, eCRF monitoring)? A17: Monitoring refers to clinical research monitoring done by the Sponsor of a clinical trial in order to fulfill the FDA Sponsor requirement for monitoring (per 21 CFR 312 Subpart D). Monitoring includes but is not limited to review of the human subject protection activities at a clinical site, review of conduct of a clinical trial to ensure that the trial is conducted in accordance with the approved protocol, FDA Regulations and GCP, and review of the data generated to ensure that it is accurate and reliable. Q18: In the PWS one of the Essential Characteristics listed is quote mark Have the ability to build and track monitoring schedules. quote mark Does this refer to monitoring other sites schedules or does this refer to subject schedules/calendars? A18: The statement quote mark Have the ability to build and track monitoring schedules quote mark refers to the scheduling of clinical monitoring visits by the IND sponsor's monitoring personnel at USAMMDA CSSD. Q19: In the PWS one of the Essential Characteristics listed is quote mark Generate, sign, and route required monitoring reports. quote mark Do you have a list or examples of what the Army considers quote mark required quote mark reports? A19: A clinical monitoring report is required to be written following each site Qualification, Pre-study, Initiation, Interim, and Close-out monitoring visit. Q20: When conducting the Remediation for the CoN testing, if significant changes are required to the solution, how are the services to implement these changes billed? A20: Billing will be against CLIN 0002 upon successful completion of the remediation. The contractor may partially bill against this CLIN throughout the 9 month period of performance in the event that remediation is required more than once. The contractor will not bill for remediation if no remediation is required. Refer to USAMRAA local clause 52.004-4005 Army Electronic Invoicing Instructions for instructions on submitting invoices (attached). This clause will be filled out by the contracting office upon award. Q21: Our licensing model allows for unlimited users, but is based on the number of active trials being managed. Can you provide an estimate of the number of studies that the Army intends to manage in the chosen system? A21: It is estimated that we will manage 30-40 trials in the system at one time. Q22: In the Evaluation Factors for Award document, in Section 1a., one of the criteria listed references implementing a USAMMDA initial trial in the CTMS. Can you detail the level as to what will be included in creating budget and financials along with a comprehensive coverage analysis, creating study calendars and case report forms? A22: We would anticipate that the implementation of the initial clinical trial will include entering the protocol information, entering contact information for team members, entering the study events and milestones, entering the case report forms to be monitored, entering the monitoring plan schedule for visits, and configuring the monitoring report output and routing. Creating monitoring budgets would be a benefit if the system, but is not a requirement of the PWS. We do not require that the implementation needs to include creating case report forms. Q23: W81XWH-13-R-0022-ATTCH5-SUBMISSION.pdf states that information required from the contractor's Point of Contact needs to include quote mark level of authority quote mark. Does CSSD have pre-existing levels of authority that need to be used here, or is this posed as an open-ended requirement where the contractor is expected to describe the level of authority in their own terms? A23: W81XWH-13-R-0022-ATTCH5-SUBMISSION.pdf has been revised to eliminate improper formatting and 1.2.2(d) is now 1.2.3 (see attachment to this amendment). For clarification, the Contractor POC is not part of Past Performance information, which requires separate a POC as part of past performance reference information. There is no pre-existing level of authority that must be used, but the POC must have the authority within your company to hold discussions/negotiations with the Government and have full authority to bind the Offeror to a contract. A job title will suffice. The Offeror shall also provide a POC who is responsible for reviewing any applicable performance evaluation reports rendered by the Government if one POC does not have the authority to do both.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-13-R-0022/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02983978-W 20130210/130208235959-86078a1a8a74fe480c5cbc919251fd81 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |