Myocardial Stem Cell Trial. CCS
took over a failing phase 1 study for this venture capital funded,
regenerative therapy development company. CCS provided comprehensive
services to redirect this trial starting with rewriting the protocol
and CRFs to site management, monitoring, data management, biostatistics,
executive committee management and overall project management. The
trial is back on track, and CCS is working with the company to develop
and execute its phase 2 protocol. CCS has worked on 4 myocardial
stem cell trials for multiple indications through its core laboratory
and clinical operations service offerings.
Comprehensive Investigator Sponsored Study.
A large pharmaceutical company asked CCS to manage all aspects of
a 400 patient/60 site, investigator sponsored heart failure trial
including writing the protocol, IND submission, site selection,
regulatory document management, site monitoring, data management
and statistics, SAE reporting, DSMB and Steering Committee management,
drug distribution, etc. We selected a set of sites from our investigator
database with capabilities and interests matched to the protocol.
We developed trial milestones jointly with the sponsor for completion
of study startup, first/last patient enrolled, first/last monitoring
visit, data lock and statistical analysis. We achieved regulatory
approvals for all sites 3 months ahead of the projected timelines
and enrolled the last patient 4 months ahead of our projected timeline.
Clinical Development Plan. CCS was recently approached
by a venture capital firm together with its funded start-up company
offering a diagnostic device for ACS. The company required assistance
in clinical development planning and clinical trial management.
Working closely with senior management and investors, CCS wrote
a four year Clinical Development Plan comprising 7 clinical studies,
all timed, sequenced and costed using CCS’ proprietary Project
Time-Cost Model. The Plan was approved by the Board, and we are
currently implementing the Plan by operationalizing the first ED
Large Phase III Trial. A mid-sized pharmaceutical
company asked CCS to manage the North American operation of its
global, phase III trial. The trial involved over 350 sites
(over 200 of them in North America), enrolling over 4,000 subjects
with acute heart failure. CCS successfully competed with a large,
global CRO on the basis of CCS’ accelerated site selection
process. CCS selected sites from its Investigator Database with
capabilities required for this complex, invasive study. Sites were
pre-qualified based on responses to written questionnaire and one-on-one
interviews. CCS was also selected to energize patient accrual through
its intensive site management program. CCS ultimately managed: site
selection, study start-up, regulatory document collection and approval,
site contracting and payment, Executive Committees including DSMB
and CEC. Experienced CCS heart failure nurses prepared patient dossiers
for adjudication by the global CEC of over 5,000 cardiovascular
end points. The CCS medical monitor managed the global medical monitoring
staff, and CCS nurses staffed a complementary 24/7 global help line.
CCS was increasingly called upon to energize and accelerate this
important global trial as well as multiple other trials for this
Hemodynamic Trials. CCS has extensive experience
in conducting hemodynamic trials for patients with advanced heart
failure. We have conducted two dose-ranging trials with hemodynamic
end points for neurohormonal antagonists, ultimately targeting acute
decompensated heart failure patients. In both trials we managed
the North American sites for studies that entailed elective admission
for hemodynamic monitoring. We learned important lessons regarding
site selection, study start-up and IRB approval processes for complex
trials such as these. The CCS Medical Director presented and published
the data from one of these trials and served as medical monitor.
We also provided 24/7 clinical help line staffed by cardiac nurses
to respond to site questions regarding enrollment and protocol execution.
These, and other, steps enabled both trials to meet their enrollment
goals and conclude successfully.
Hemodynamic Core Lab. In addition to managing hemodynamic
trials, CCS provides a hemodynamic core lab for central quality
review and processing of hemodynamic monitoring. CCS provided this
service in response to the FDA’s request for a central core
lab to process hemodynamic tracings for a device trial for acute
decompensated heart failure patients, since the sponsor’s
composite primary end point included hemodynamic measurements. The
core lab has proved to be invaluable in terms of real time monitoring
and feedback on the quality of the multiple pulmonary capillary
wedge pressures obtained for each patient in the trial.
Remodeling Study. A large pharmaceutical company,
experiencing enrollment delays, asked CCS to identify new sites
for a protocol designed to look at ventricular remodeling in heart
failure subjects. The methodology used for the remodeling
primary end point was highly selective. CCS was able to select
sites from its Investigator Database with the requisite capability.
CCS’s site selection, study start-up and site management program
dramatically increased enrollment rates allowing the Trial to finish
Registry Study. CCS assisted a mid-size pharmaceutical
company in administering a global observational study of over 5,000
CAD patients for 83 sites in the US, Canada, Europe, South America.
The objective of the study was to provide data on cardiovascular
end points in preparation for the sponsor’s phase III imaging
study. CCS provided site selection, regulatory document collection,
site management, distribution/tracking of non-drug supplies to sites,
medical monitoring, project management and participation in publication
Regenerative Therapy Study of STEMI. This venture
capital funded start-up company turned to CCS for rescue of its
failing phase I regenerative therapy trial. CCS assumed all functions
immediately, re-wrote the protocol and CRFs, re-trained sites that
were bewildered by their prior study experience, monitored sites,
implemented a new data management system, and performed statistical
analysis services. The study is now back on track and meeting milestones
for completion and FDA review.