Combine Solicitation – A– CSP Monitoring Svcs – FY15 501-15-1-283-0002
Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: A-- CSP Monitoring Svcs - FY15 501-15-1-283-0002
Classification Code: A - Research & Development
Solicitation Number: VA25815R0045
Contact:
Setaside: Total Small BusinessTotal Small Business
Place of Performance (address):
Place of Performance (zipcode): 87106
Place of Performance Country:
Description:
The
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.
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.
" 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)
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
"
" 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:
o Study Team recommendations
o Subject accrual rate at the site
o Total number of subjects to be enrolled at the site
o Complexity of the study protocol
o Data collection and record keeping proficiency at the site
o Observations 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:
o Tentative Agenda
o Estimated time needed on site with the Site Investigator/Coordinator
o Specific 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
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.
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.
Link/URL: https://www.fbo.gov/spg/VA/VAWTHCS519/VAWTHCS519/VA25815R0045/listing.html
Modification to a Previous Presolicitation Notice – SINGLE FAMILY POST CLAIM REVIEWS
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