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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 30, 2015 FBO #4936
DOCUMENT

A -- CSP Monitoring Svcs - FY15 501-15-1-283-0002 - Attachment

Notice Date

5/28/2015
 

Notice Type

Attachment
 

NAICS

541611 — Administrative Management and General Management Consulting Services
 

Contracting Office

Department of Veterans Affairs;SAOW/NCO 18;4135 S. Power Rd., STE 103;Phoenix, AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25815R0045
 

Response Due

6/16/2015
 

Archive Date

8/15/2015
 

Point of Contact

Enrique Rivera
 

E-Mail Address

e.rivera@va.gov<br
 

Small Business Set-Aside

Total Small Business
 

Description

The Department of Veterans Affairs, Veterans Health Administration, VISN 18 intends to issue a Request for Proposal for the services of an experienced Contractor to serve as a provider of clinical trial site monitoring CRQA services. The Contractor shall serve as a study Clinical Research Quality Associate (CRQA) for the clinical trials conducted by the VA Cooperative Studies Program (CSP). The period of performance shall be a Base period (award through 9/30/2015) and two (2) one-year Options. This is a pre-solicitation notice for commercial services prepared in accordance with the format specified in the Federal Acquisition Regulation Subpart 5.203(a), as supplemented with additional information included with this notice. The acquisition will be a set-aside 100% for small business in accordance with FAR 19. The North American Industry Classification Code (NAICS) is 541611, Administrative Management and General Management Consulting Services, with a small business size standard of $15,000,000.00. Evaluation and award will be made in accordance with FAR 15.101-1, Tradeoff Process. I.A summary of the evaluation criteria used for source selection is listed below to assist you in determining your qualifications for this solicitation: A.Factor # 1 - TECHNICAL PROPOSAL The evaluation will be divided into four (4) sub-factors and supporting criteria. Sub-factor 1, Professional Certifications/Degrees, is more important than sub-factor 2. Sub-Factor 1: Professional Certifications/Degrees & Experience - "Bachelor Degree in a medical or scientific field with five years or more research monitoring experience, or "Licensed Health Care Professional with five years or more research monitoring experience. "Experience: This applies to both the Offeror and its staff, and will determine Offeror's ability to provide qualified staff and required licensing under this contract. The Offeror shall identify that it has qualified staff to provide services indicated in the solicitation, which offer the most likelihood of successful performance. "Current copy of certification (i.e., Specialty/Sub-specialty, ACRP, SCRA, etc.) "Copy of resume of curriculum vitae with a minimum of 3 current references "Research Experience (preferred) Sub-Factor 2: Safeguarding of Patient Health Information (PHI) - "Describe Offeror's procedures used to safeguard VA patient records under this contract. The Offeror's approach should include documentation of physical security of records and steps taken to prevent disclosure of an individual record, report or other private information of the patient. Sub-Factor 3: Technical Abilities/Capabilities "Basic Computer knowledge "Software knowledge in Microsoft Office Programs (e.g. Word, PowerPoint, Excel, etc.) "Human Subjects and Good Clinical Practices (GCP) Certification (Preferred) Sub-Factor 4: Veteran Preference In an effort to achieve socioeconomic small business goals, depending on the evaluation factors included in the solicitation, VA may evaluate Offerors based on their veteran-owned or service-disabled veteran-owned status, their proposed use of veteran-owned or service-disabled veteran-owned small businesses as subcontractors, and their past performance on adherence to subcontracting plan requirements. B.Factor # 2 - PAST PERFORMANCE: The Government will conduct a performance risk assessment based upon the Past Performance of the Offeror as it relates to the probability of successful accomplishment of the work required by the solicitation. The Past Performance proposal evaluation will consider such things as an Offeror's business practices, customer relationship, and ability to successfully perform as proposed. For the purpose of this solicitation, currency is performance occurring within the last five (5) years through the solicitation release date. Past Performance includes current on-going (present) performance. Relevance will also be evaluated in the overall Past Performance rating (i.e. very relevant, semi-relevant, and not relevant). Ratings will consider the Offeror's Past Performance considering currency, relevancy, sources, context, and trends. C.Factor #3 - PRICE "The Government evaluation team will conduct a Price evaluation of each Offeror's Pricing Schedule to determine whether or not each proposal complies with the stated criteria: "Reasonableness". If the proposed price is determined to be reasonable, a REASONABLE rating will be given; if found to be unreasonable, an UNREASONABLE rating will be assigned to the price evaluation factor. "Prices will also be analyzed to determine whether they are realistic for the work to be performed, reflect a clear understanding of requirements, and are consistent with the corresponding Technical Proposal. Proposals must include the cost of the entire service including overhead and profit. II.A condensed version of the SOW has been enclosed for your review. STATEMENT OF WORK (SOW) 10/24/2014 SPECIFIC TASKS Task 1 - CRQA visits (with pre and post work) a.Subtask 1 - Site Initiation Visits - one to three days The CRQA shall conduct site initiation visits as defined by the CRQA Plan with the support of a Lead CRQA from the SMART. The visits shall be scheduled after the Investigator's Meeting. When conducting a site initiation visit, the CRQA shall perform all of the following, as relevant to the design of the trial: "Protocol procedures including inclusion/exclusion criteria "Subject informed consent process "Screening procedure "Randomization procedure "Investigational Product Accountability "Unanticipated Adverse Event reporting and Serious Adverse Event Reports "Source document requirements and availability "Case Report Form (CRF) completion, correction, QA procedures "Institutional Review Board (IRB) policies and procedures (i.e., adverse events and protocol deviations) "Regulatory and other study document completion and maintenance "Site correspondence with sponsor, CRQA and maintenance "Un-blinding procedures of a blinded study "Other related protocol procedures The CRQA shall assure the following regulatory information is present in the site files: "Current IRB approval - protocol/amendments "Current IRB approval - consents(s) "Current IRB membership list or documentation of IRB compliance "Investigator agreements "Financial disclosures "Investigator curriculum vitae (CV) "Research and indemnity (if applicable) agreement "All training requirements - GCP, Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protections (HSP) Additionally, the CRQA shall assure the following Study Management Documents are completed (if applicable) and appropriately filed in the Essential Document Binder (Regulatory Binder): "Delegation of Authority Form or CRF Authorization Log "IRB policy and procedures (i.e., adverse event and protocol deviation reporting) "IRB correspondence "Sponsor correspondence "Study contact list "Subject list "Site Visit Log "CRFs (all versions) "CVs "Medical license(s) b.Subtask 2 - Conduct routine CRQA visit for assigned site - one to four days The CRQA shall conduct the routine CRQA visits as defined by the CRQA Plan. When conducting a routine CRQA visit, the CRQA shall perform an evaluation of the following tasks, if appropriate: "Check for protocol compliance "Review Essential Document Binder "Conduct subject data review "Verify CRF data against Source Documents "Review Source Documents for Adverse Events (AE)/Serious Adverse Events (SAE) "Review CRFs for accuracy and legibility "Check for CRF submission to Data Coordinating Center "Perform investigational product accountability "Determine follow-up actions to be taken "Provide relevant GCP Training "Hold exit interview with study team to discuss site status c.Subtask 3 - Conduct study closeout visit for assigned site - one to four days The CRQA shall conduct study closeout visits as defined by the CRQA Plan with the support of a Lead CRQA from the SMART. Visits shall be conducted after all subjects have completed the study and all data has been submitted, or earlier if so directed by the SMART. When conducting a study closeout visit, the CRQA shall: "Discuss site close-out procedures with staff "Assure submission of data "Review Essential Document Binder for completeness "Check for final disposition of investigational product "Retrieve documents for Sponsor files "Discuss record retention with investigator d.Subtask 4 - Prepare site visit reports and summary letters Within seven (7) calendar days of site visit, the CRQA shall: "Complete a site visit report (using a pre-approved template) and prepare a follow-up QA summary letter, if applicable. "Provide QA documents, which may include reports and follow-up summary letter, if applicable, to the SMART "Inform the SMART Lead CRQA of recurrent and/or serious compliance deficiencies "Assist with implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency e.Subtask 5 - Additional notes about preparing and conducting site visits "Scheduling -The CRQA shall complete an announcement letter, a site visit report and a letter with the summary of findings from each site visit. Periodic conference call participation with multi-center clinical trial personnel and telephone contact with site staff shall be required. "Special Requirements - The CRQA's reporting requirements will necessitate computer program access and literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, as well as Internet capability in order to transmit documents and access email and correspondence. "Frequency of Visits - The frequency and timing of CRQA visits will be determined by SMART for each site based on the following: oStudy Team recommendations oSubject accrual rate at the site oTotal number of subjects to be enrolled at the site oComplexity of the study protocol oData collection and record keeping proficiency at the site oObservations and corrective actions from previous monitoring visits "Preparing for Visits - Prior to the CRQA visits, the CRQA shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.) The CRQA shall contact the site coordinator to set up a date/time for the visit and to discuss: oTentative Agenda oEstimated time needed on site with the Site Investigator/Coordinator oSpecific documents needed for review Task 2 - CRQA Visits (without pre and post work) a.Subtask 1 - Meeting or other visits - one to four days 1.Kickoff Meeting 2.Investigator's Meeting 3.Other [ The CRQA may be required to attend the Kickoff Meeting held prior to the clinical trial start where all trial participants will receive training for specific study procedures and requirements. The CRQA shall attend the Kickoff Meetings to receive training on study protocol and procedures. The CRQA may be required to provide training to site personnel on the requirements of the monitoring plan. Attendance at Annual Investigator Meetings or other training meetings may also be required to receive or present additional study training. b.Subtask 2 -Support of other the CRQA conducting visits - one to four days on site "The CRQA may support another CRQA in conducting site monitoring visits at the request of the Lead CRQA III."Offeror" and "Reference" past performance questionnaires. These forms (Exhibits B & C) are enclosed to provide interested firms additional time for contacting potential references. Please follow the instructions to ensure compliance with the past performance criteria. Solicitation number VA258-15-R-0045, will be posted on or about 13 May 2015. The date for receipt of offers shall be 3 June 2015. Questions concerning this pre-solicitation should be directed to Enrique.Rivera@va.gov, with the email subject "VA258-15-R-0045, Monitoring GCP CRQA Services". All questions must be sent formally by email no later than close of business on 11 May 2014. ? EXHIBIT B - OFFEROR'S PERFORMANCE RELEVANCY QUESTIONNAIRE Provide the following information requested in this format for each of the projects/contracts being described. Projects may be ongoing and cannot have been completed any later than 5 years prior to the solicitation issue date. Provide frank, concise comments regarding YOUR PERFORMANCE on the contracts you identify. Use as much space as required. A.Offeror (Your) Name (Company/Division): B.Project/Contract Title: C.Contract Specifics: 1.Description of Effort as Prime ___ Subcontractor ___ 2.Contract Number: 3.Award Date: 4.Contract $ Value: 5.Current Schedule: 6.Estimate/Final Completion Date: D.Provide detailed description of the work performed under the contract, and describe why you believe the work is very relevant, relevant or semi-relevant to this solicited project. At a minimum, address the following: (Use as much space as necessary) 1.Describe the specific elements of the work performed by your firm. 2.Indicate what elements of work, if any, were performed by your major subcontractors and indicate if those same subcontractors will be used on this IDIQ. 3.Address any technical areas about this project/contract you consider uniquely relevant to this solicitation. E.Point of Contact for Owner/Government agency Contracting Officer and or inspector; include a current phone number and facsimile number. Email address is also desired. 1.Name:Title: 2.Company/Agency: 3:Phone/Fax #" 4.Email address: End of Questionnaire Requirements - Prepare and send Exhibit C Package (Past Performance Questionnaire) to the reference(s) for each of the projects discussed.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAWTHCS519/VAWTHCS519/VA25815R0045/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-R-0045 VA258-15-R-0045_2.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072555&FileName=VA258-15-R-0045-002.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072555&FileName=VA258-15-R-0045-002.docx

 

File Name: VA258-15-R-0045 S02 Exhibit B Offeror's Performance Relevancy Questionnaire.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072556&FileName=VA258-15-R-0045-003.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072556&FileName=VA258-15-R-0045-003.docx

 

File Name: VA258-15-R-0045 S02 Exhibit C Past Performance Questionnaire - Rev1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072557&FileName=VA258-15-R-0045-004.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072557&FileName=VA258-15-R-0045-004.docx

 

File Name: VA258-15-R-0045 P07 WD 05-2362 (Rev.-16).docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072558&FileName=VA258-15-R-0045-005.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072558&FileName=VA258-15-R-0045-005.docx

 

File Name: VA258-15-R-0045 Copy of S10 Attchmt 1 - Price Schedule - Monitoring Svcs.xlsx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072559&FileName=VA258-15-R-0045-006.xlsx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2072559&FileName=VA258-15-R-0045-006.xlsx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: VA Cooperative Studies Program Clinical Research;Pharmacy Coordinating Center (CSPCRPCC);2401 Centre Ave., SE;Albuquerque, NM

Zip Code: 87106
 

Record

SN03745522-W 20150530/150529040013-efd0d09d60b9d58fdbc43529c27c63ad (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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