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CLINICAL DEVELOPMENT

CLINICAL DEVELOPMENT

Clinical Services

Areas of Therapeutic Expertise

Since 2008, Now Biopharma (originally Comprehensive Research Associates) has run over 100 Emergency Medicine clinical research studies, the majority of which were in the acute care space (ER, ICU, and OR). These studies covered the following areas:

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  • Acute heart failure

  • Acute myocardial infarction and acute coronary syndrome

  • Arrhythmias

  • Cardiac arrest

  • Infectious disease

  • Neurologic emergencies

  • Renal failure

  • Trauma

Medical Site Collaboration

We have ongoing and robust collaborations with 60 Emergency Medicine research departments, among the very best acute care centers in the United States.  Our participating research sites have the following common characteristics:

 

  • Involved in FDA clearance studies within the last year.

  • Excellent trial enrollers. Feature excellent geographic and demographic representation, thus meeting FDA requirements that a pivotal study enrolls a disease specific cohort representative of the United States population (e.g., 50/50 male/female, 15% African American, 15% Hispanic, 10% Asian).

    • This prevents the problem of low or inexact enrollment sometimes seen at other sites (typically after many months of trial duration).

    • This obviates the need for a pro forma Site Qualification Visit, saving ~$3,000 per site.

  • Excellent protocol compliance.  

    • This mitigates the likelihood of adverse regulatory authority outcomes (e.g., Refuse to File) due to non-adherence to Good Clinical Practices, which can damage the company brand.

Clinical Protocol Review

Coupled with the aforementioned site characteristics, we are highly skilled in conducting rigorous clinical protocol review that has resulted in over 100 FDA-approved protocols (of which many resulted in FDA clearance of the investigational product). We know from deep experience whether the protocol design can be successfully executed in the acute care research setting. The following elements are carefully scrutinized:

  • Evaluation of patient enrollment

  • Operational challenges

  • Mechanics of study enrollment

  • Patient follow up probability 

We are also well experienced in corresponding and meeting with the FDA to achieve successful regulatory outcomes on behalf of clients.

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