Company Profile

Bert Spilker

Contact Us:

8004 Overhill Road
Bethesda, Maryland

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com

Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Professional Consulting: Key Areas

    What to Do How to Do It Key Issues
    I. Strategy Setting
    - Overall Brainstorming Avoiding problems
    - Clinical Telecons Fastest route to goals
    - Regulatory Written proposals Regulatory acceptability
    II. Planning
    -What to do Meetings What can be eliminated
    -When to do it Proposals What can be delayed
    -Who to do it Periodic reviews Regulatory acceptability
    -How much to do it Due diligence Can costs be cut
    III. Implementing Plans
    -Keeping on track Weekly project meetings Identify potential issues/problems
    -Preventing tangents Ad hoc meetings Should activities be simultaneous or sequential
    -Solving problems Monitoring progress versus plans
    IV. Preparing Documents
    -White papers Prepare a synopsis first Other issues to address
    -Final study reports Develop shells/templates How can we support our position
    -Regulatory submissions Create boilerplate
    -Clinical protocols
    V. Review Documents
    -Are key messages included Content experts Are issues/problems transparent
    -Is the discussion complete Method experts Is the interpretation complete
    -Is the structure sound Is the report logical
    -Is the organization logical Is the report supported by evidence
    -Is anything missing
    VI. Miscellaneous
    Shorten drug development Review documents, interview staff and make recommendations
    Raise money Contact my financial associates and others
    Locate other experts Contact my extensive network of independent Consultants

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