Protocol Writing

Across the spectrum from general concept to study outline, from outline to synopsis, from synopsis to full text protocol draft, draft revisions through final protocol, or assistance with protocol amendments, Pacific Pharma Group consultants can assist you with your protocol design and writing needs.

Product Development Strategy

Our capacity to develop new chemical entities outstrips our capacity to bring these entities through the clinical trial process to approval. How do you select the best candidates, and what is the best way to move these candidates forward?

Pacific Pharma Group consultants focus primarily on: Early development, i.e. from pre-IND planning through proof of concept, and Global development strategies, particularly for Japan and other Asian jurisdictions.

Medical Monitoring

Adverse events arise in every clinical trial. Effective monitoring requires thorough knowledge of the study drug plus a keen sensitivity for the well being of the study participants coupled with a balanced sense for interpretation of adverse event causality and relationship to the study drug.

With 7 years as a Consultant, over 13 years of experience as a full-time Investigator and an additional 9 years of primary care medical practice experience, Dr. Ruckle can provide that balance in a variety of clinical domains and with many classes of compounds.

Data Safety Monitoring Board

As with Medical Monitoring, Data Safety Review requires a balanced look at adverse events and other clinical data in terms of the characteristics of the study drug and eventual use in the target clinical population.

Is it safe to dose escalate? Should you continue or suspend dose administration? Should a trial continue or be terminated? Does your experience indicate the protocol should be amended? Should the compound move forward? Does the product development strategy need further consideration? Do you have all the data you need to make these decisions?

While the decision for these and other important questions is generally up to the sponsor, Data Safety Review members need to review the data and be prepared to make responsible recommendations.