Building Safety into Every Aspect of the Program

Drug Discovery Consulting Services

Drug discovery is the process of finding new chemical and biological entities for unmet medical needs. In order to be really good at this speciality, experts must understand the downstream part of the process, namely what is needed to solve the problems that exist. For this reason, Speid & Associates Drug Discovery Consulting Services include the following areas of expertise and support:

  • Disease definition in terms of the challenge
  • Development of the Target Product Profile
  • Development of the overarching Regulatory Strategy
  • The current competitive landscape
  • The patient’s perspective
  • Drug discovery of new molecules consulting services

    Drug Development Consulting

    Drug development is the process of moving a molecule through a carefully planned and executed process. It involves conducting clinical trials, and then evaluating the results to determine which patients should be administered the drug under study.  There are many pieces to the drug development process. Speid & Associates are experts in drug development consulting services, and can advise on the following areas:

    • Research 
    • Drug discovery
    • Drug development
    • Clinical biostatistics consulting
    • Phase 1 clinical trials
    • Phase 2 clinical trials
    • Phase 3 clinical trials
    • Phase 4 clinical trials
    • Line extension in the postmarketing phase 
    • 505 (b) (2) drug development
    • Other aspects of drug development, as needed

      Drug Safety Experts

      Every drug that is developed has the potential to create safety concerns.  There is no such thing as a drug that does not have risks.  The dose administered, the patient to which it is administered, the process of research the drug has undergone, all have an influence on the safety of the drug when it is used in practice. If someone says a drug is safe, without qualifying for whom it is safe, as often occurred during COVID19 crisis, then you should know that they are novices as far as drug safety is concerned.

      The speciality of drug safety collects data regarding the use of the drug, and analyzes the data, so that an understanding of the safety profile of the new drug can be gained. This safety profile will enable those involved in evaluating the drug before it is commercialized, to gain an understanding of who the drug is safe enough to be administered to.

      Drug safety experts are a crucial part of any drug development team. Drug Safety experts must have integrity, and be independent, even though they work in a company setting. They must have enough integrity to put the safety of patients first, even over employer’s profits, and the company’s interests.

      The Drug Development Consulting team will help with the following challenges:

      • Removal of Clinical Holds
      • Drug Development Consulting Services
      • Finding out why patients died during the clinical trial
      • Finding out which patients should not receive the drug
      • Finding out the best dose to test in the clinical trial
      • Development of a strategy for finding the most appropriate dose
      • Writing of safety reports including analysis of safety data over a period of time