Therapeutic Expertise...

ONCOLOGY

TRIBE has deep and wide-ranging experience in oncology drug development. Our combined experience in oncology includes the monitoring and management of Phase 1 maximum tolerated dose, Phase 2 proof of concept, and Phase 3 global trials. We have experience in pediatric and adult populations and in solid tumor and hematologic indications. And, our track record is proven. Members of TRIBE previously held lead monitoring and management roles on trials that resulted in the approval of CAMPATH as front-line therapy in CLL and CLOLAR in pediatric ALL.

Specific targets within oncology we have monitored and/or managed include:

CARDIOLOGY

TRIBE has a wide range of cardiology experience that spans numerous indications including diastolic heart failure, cardiac surgery, interventional cardiology, atrial fibrillation, acute coronary syndrome, hyperlipidemia, essential hypertension, and resistant hypertension. However, TRIBE’s specialization within cardiology is in pulmonary arterial hypertension or PAH.

The members of TRIBE have worked together for approximately 4 years in the area of PAH. Our experience includes 4 global Phase 3 trials in PAH and responsibility for over 1,200 on-study subjects worldwide. Our experience also goes beyond traditional monitoring and project management and includes significant contribution in study design, protocol writing, formation of Adjudication Committees and DSMBs and Charter writing. We have also worked directly with every Key Opinion Leader in PAH across the globe, gaining their insight on regulatory strategy, protocol design, and site selection. In the United States where TRIBE’s services are focused, we have successfully recruited virtually every center conducting research in PAH. Most importantly, we have maintained our relationships with these Investigators and KOLs and as a team continue to be very active in this disease area.

There are many subtle but extremely important details to consider when conducting a clinical study in PAH. For example, our team understands the significance of regulating oxygen use throughout the study and the importance of standardizing the 6 minute walk test across all sites. It is these details among many others that can make or break your study. Again, the members of TRIBE understand the intricacies of conducting studies in this disease area and our experience can significantly benefit your PAH project.

ENDOCRINOLOGY/METABOLIC SYNDROME

Our team has worked in all phases of endocrinology clinical research with various study medications and devices to better control Type 1 and Type 2 diabetes and metabolic syndrome (sometimes referred to as Syndrome X). We have developed and written protocols in these indications and have selected premier sites with whom we have established and maintained excellent relationships.

We have a special interest in the diabetes arena as one of our own team members, Michelle Kaelin, Sr. Project Manager, has lived with Type 1 diabetes for more than 25 years. She has coordinated and managed multiple diabetes studies as well as been a participant in research trials for this indication. Michelle understands the science of her disease and has kept up with ongoing research in the area. Her knowledge and experience are invaluable in the research process from the development of the protocol and identification of appropriate subjects to the importance of adequate subject follow-up. Understandably, Michelle’s desire to find ways to obtain tighter glucose control is very personal. It is safe to assume that you will not find another project manager with more dedication to your endocrinology project.