Nonclinical and clinical research programs


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Beckloff Associates believes that integrating nonclinical and clinical research programs facilitate rapid development time and accelerate the movement of new products to worldwide commercialization. With assistance from our network of expert consultants, our nonclinical research programs achieve timely completion of appropriate nonclinical work without expending resources on unnecessary studies. Nonclinical study audits are also performed to assure Good Laboratory Practice (GLP) compliance. Utilizing our in-house resources and network of clinical experts, our clinical expertise allows us to expedite the preparation and initiation of clinical protocols. Rigorous monitoring of clinical studies is performed to ensure scientific integrity and GCP compliance of all data. This planning provides the clinical, economic, and humanistic rationale for the development of commercially successful products.

 

Nonclinical Development

  • Nonclinical project management
  • Preparation of nonclinical development plans
  • Development and review of nonclinical study designs and protocols
  • Liaison activities with regulatory authorities
  • Integration of nonclinical and clinical programs
  • Selection, qualification, management, and monitoring of nonclinical study sites
  • Good Laboratory Practices (GLP) audits
  • Preparation and evaluation of nonclinical reports
  • Preparation of non-clinical sections for INDs and NDAs


 

Clinical Development

  • Clinical Program
    • Clinical program and management
    • Preparation of clinical development plans and study designs
    • Specialized research studies
    • Network of clinical expert consultants
    • Coordination of team of experts
    • Liaison activities with regulatory authorities
  • Clinical Operations
    • Clinical supply management, including labeling and packaging
    • Selection, qualification, management, and monitoring of bioanalytical laboratory, Clinical Research Organization (CRO), clinical trial sites and investigators
    • Good Clinical Practices (GCP) Audits
    • Medical writing
    • Preparation and quality assurance of protocols, case report forms, informed consent forms, Investigator's Brochure, Final Study Reports, Expedited IND, and Postmarket Safety Reports
    • Preparation of clinical sections for INDs and NDAs