Scientifically Driven CRO Services

The classic CRO/Site model no longer works for analgesic clinical trials. The industry has matured such that producing data on time and on budget simply meets baseline criteria. Clinical trial sponsors want more than just efficient project management. They also want program-wide scientific support to increase the chance of a positive clinical trial outcome. Utilizing our proprietary technologies, placebo response can be mitigated; increasing the likelihood of study success.

CRO SERVICES

Lotus’s CRO offering has been adapted to fit the needs of complex and nuanced analgesic investigations.
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SITE SERVICES

We have one of the world's largest analgesic clinical trial database with over 12,000 potential study volunteers
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PLACEBO RESPONSE MITIGATION

The properly
educated patient can be your greatest ally in producing a positive analgesic clinical trial.
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WEBINAR: Expert Review of Recently Released
FDA Analgesic Draft Guidance


In February of 2014 the FDA released a draft guidance document related to the development of drugs for analgesic indications. The importance of this document cannot be over emphasized in that it speaks to the current mindset of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products (DAAAP). A multitude of topics are covered in it, including specific information regarding the following:

  • The development of new molecular entities versus reformulations
  • Requisite paths to specific analgesic indications
  • Early phase requirements
  • Appropriate endpoint selection
  • Recommended strategies for administration of rescue medication
  • Data imputation guidelines
  • Acceptable patient reported outcomes etc.