SOURCES SOUGHT
A -- Clinical Biostatistical Consulting
- Notice Date
- 12/10/2018
- Notice Type
- Synopsis
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- 10 General Green Avenue Building 1 Natick MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- DVC0624-BOT-18
- Response Due
- 1/11/2019
- Point of Contact
- Greg Smith, Contract Specialist, Phone 301-619-2895, - Leo J. Fratis, Contract Specialist, Phone 2405861523
- E-Mail Address
-
greg.d.smith2.civ@mail.mil, leo.j.fratis.civ@mail.mil
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice for Clinical Biostatistical Consulting supporting DynPort's Recombinant Botulinum Vaccine A/B (rBV A/B) Program; specifically the Phase 3 Clinical Study and BLA. This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts or quotations. The objective of this notice is to identify businesses in the area of statistical services capable of providing expertise and opinion supporting the Phase 3 study design and analysis and planning, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), to submission of Biological Licensing Application (BLA). Responding parties must be able to demonstrate expertise and capabilities in the following areas: • Phase 3 Clinical Trial Support  Review and consultation regarding Phase 3 study design, endpoints and objectives, statistical power  Collaborate, review and consult for CRO authored statistical analysis plan and methods • BLA Planning, ISS and ISE Development and BLA Submission  Collaboration for the planning, implementation and finalization of deliverable supporting BLA  Evidence of expertise and knowledge to plan, develop and support the required ISS and ISE, Module 2 & 5, supporting a BLA submission • ITAR Compliance - Ability to comply with the requirements for ITAR • FDA Communications/Meeting Support  Performance of ad hoc analysis requested by the agency  Participation in FDA meetings as required, i.e. Pre BLA  Review and opinion for FDA correspondence, information requests and communications as received NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (10-DEC-2018); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/notices/0ca8a45eaa256265e326106bbf0f7779)
- Record
- SN05170236-F 20181212/181210230015 (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 |