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 Contact Information: DVC requests that you provide a response directly to Alesha Subasic at alesha.subasic@gdit.com indicating if you have or do not have the expertise, capabilities and interest in pursuing further discussions. Should DVC elect to pursue discussions, a Non-Disclosure Agreement will be executed. Should you have interest, please include in your response the following Business information in your email: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative/business), including names, titles, addresses, telephone and fax numbers and email addresses. e. Type of Company (i.e. small business, 8(a), woman owned, veteran owned, etc). Disclaimer: This notice does not obligate DVC to award a contract or otherwise pay for the information provided in response. Note that DVC will not entertain questions regarding this Market Research; however, general questions can be presented in your response. Confidentiality: No proprietary, classified, confidential or sensitive information should be included in your response.
