Clinical Pharmacology Consulting
 
 

DecisionLine's Clinical Pharmacology Consulting team is composed of ten MD and PhD research scientists, including internationally established clinical pharmacologists. The team has extensive experience in designing and interpreting specialty phase I studies.
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As a full service unit this group can assist our clients with the entire drug development process, beginning with reviewing preclinical data, designing studies, analyzing and interpreting study data, writing final reports and advising on market placement of a new product.

In addition, DecisionLine’s Clinical Pharmacology Team has considerable experience in non-study specific consultative work related to due diligence in acquiring new compounds, input on regulatory guidelines and general scientific assessments.

How our Consultative Services Work

Working with our biostatisticians, neuropsychologists and clinical staff, the Clinical Pharmacology team drives the preparation of protocols, investigator's brochures, informed consent forms and integrated study reports. The Research Scientist works closely with the Biostatistics and Data Management as well as the Clinical Neuropsychology groups in developing study designs and interpreting study results. The Clinical Pharmacology team also advises clients on regulatory matters and participates in pre-Clinical Trial Application (CTA)/Investigational New Drug (IND) meetings.

Specialty Expertise

With our extensive experience in CNS compounds, the Clinical Pharmacology Consulting group has specific expertise in the evaluation of compounds for abuse liability, cognitive and motor impairment, and drug interactions. Our scientific staff includes cognitive neuroscientists, clinical pharmacologists, molecular biologists, pharmacogeneticists and psychiatrists.

Contact our Clinical Pharmacology Consulting group

  

Scientific evaluation & strategic expert opinion

Protocol development & preparation

Assessment of preclinical pharmacologic & toxicologic data

Regulatory submissions & consulting support

Drug safety assessments & integrated safety reports

Medical scientific advisory/monitoring committees

Final scientific clinical study reports

CRF & document preparation

Investigator brochures

Comprehensive literature reviews

Product comparisons

Project Management

Independent Ethics Review Board

 Studies4U

 
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