Clinical Development/Strategic Consultation
- CCS clinical thought leaders and strategic and operational consultants
work closely with sponsors and investors to develop long range clinical
development plans featuring sequenced study designs, timing and
costing based on CCS' proprietary Project Time-Cost Model. CCS clinical
thought leaders work with sponsors on regulatory issues and participate
in meetings with regulatory authorities at every step of the development
and clinical trial process. CCS consultants will also provide market
research on clinical practices, product acceptance, product economics,
literature reviews and other clinical development advisory services.
Development - Working directly with a sponsor's senior clinical
staff, CCS will either advise sponsors in protocol design and determination
of end points, or CCS will develop and write the protocol for the
sponsor. CCS employs a time-managed protocol development process
that includes interactive academic scrutiny and input into development
of end points, study design and inclusion/exclusion criteria. CCS
clinical operational managers provide practical input into study
assessments and study implementation. This process frequently results
on protocol initial acceptance by federal regulatory authorities
Informed Consent Development - Consistent with FDA and HIPAA guidelines, CCS clinical staff will develop a customized informed consent template that is tailored to the particular requirements of each sponsor's protocol and will work closely with the sponsor and the CCS sites regarding changes that may be required by local or central IRBs.
Budget Preparation - CCS financial analysts will help the sponsor develop a detailed, line item patient budget and payment plan that attempts to balance the needs of both the sites and the sponsor.
Site Selection - Utilizing the CCS Investigator Database Application which includes rich data on study performance metrics together with our intimate understanding of investigative sites, CCS can identify those sites that have direct experience/expertise that matches the sponsor's requirements for a particular trial.
Site Contracting - CCS legal and contracting staff provide centralized negotiations of site budgets and clinical trial agreements (CTAs) that is fully integrated into our clinical operations study start-up processes. Our goal is that site initiation will never be postponed by CTA negotiation.
Document Collection and Review - CCS project coordinators and
project managers use an intensive communication approach to coaching
study staff through the IRB approval process and collection of required
regulatory documents. Many CCS project staff have experience as
study coordinators, and they are an invaluable resource to site
personnel in responding to IRB queries and concerns. In addition,
CCS selects sites with central IRBs from the Investigator Database
whenever appropriate for the study.
Economic Analysis - CCS provides complete economic analysis
services including cost-effectiveness analysis, reimbursement modeling,
hospital profitability impact analysis, operational impact studies,
and various types of economic market analyses. The key feature of
CCS’ approach to economic analysis is the integration of CCS’
deep clinical expertise with respect to protocol and study design
with sophisticated economic modeling expertise. CCS economic analysts
have over 30 years of experience in health and clinical trial economics,
provider reimbursement, clinical trial economic event modeling and
costing, hospital operational flow and cost modeling, and market
analysis. CCS also has extensive experience in the operational execution
of economic analyses and fully integrates requisite financial, resource
use and cost event data collection into clinical and data operational
management processes. A list of publications is available on request.
Meeting Academic Support - CCS cardiovascular clinician
thought leaders provide direction and input into academic meeting
planning, presentations and investigator relations. CCS project
managers are experienced in the logistics of academic meeting planning.
Site Management - Recognizing
the critical importance of reaching enrollment targets in a steady
fashion, CCS uses an intensive communication process for site management.
Weekly contact with each participating site is established throughout
the study along with the review of screening/enrollment logs to
monitor progress. Because CCS site management staff are full time
and located centrally, they are able to respond to site queries
immediately. This is typically not the case when CRAs are used for
site management, because they are frequently traveling to/from sites
and not available to take study coordinator calls. With this process
in place, CCS can react quickly to site issues and problems, develop
enrollment tactics to deal with the problem or enrollment, identify
for the sponsor any rate limiting factors in the study or, in extreme
cases, in replacing an under performing site.
- CCS cardiology thought leaders and clinical staff participate
in the preparation of abstracts for presentation at major meetings
and write articles for publication.
Medical Monitoring - CCS Medical
Monitors have strong academic/medical backgrounds and are capable
of responding in a timely manner to medical questions regarding
inclusion/exclusion criteria and other clinical study issues that
Cardiovascular Event Adjudication
- CCS clinical staff have developed and implemented an effective
process for the collection, review, tracking and adjudication of
cardiovascular clinical end points for sponsor trials. The CCS process
also involves committee member identification, determination of
appropriate supportive documentation and management of committee
Advisory Board/Steering Committee/DSMB
– CCS is experienced in developing/managing advisory boards,
DSMBs and steering committees for oversight of clinical trials.
CCS professionals develop committee charters, contract with
committee members, facilitate timely payment of members, and manage
Data Management -
CCS provides both electronic data capture (EDC) and paper-based
data management services. CCS has developed a low cost EDC data
management application for registry and phase IV trials. CCS works
with a nationally recognized EDC provider to offer 21 CFR Part 11
compliant, paper CRF and eCRF data management services featuring
SAS database integration and CDISC compliant database structure.
Site Monitoring -
CCS CRAs are experienced in cardiovascular trials and geographically
dispersed. . Site monitoring in fully integrated into CCS’
site management model. CCS project managers train CRAs and sites
on CRF/eCRF guidelines, protocol implementation, and local study
coordination issues. CCS has a quality assurance program for auditing
CRAs and sites.
- CCS cardiac nurse clinicians review adverse events and prepare
SAE reports to sponsors and regulatory authorities. Given the strong
clinical credentials of its staff, CCS is well positioned to assist
sponsors in post marketing pharmacovigilance studies and data registries.
Patient Call Center -
CCS cardiac nurse clinicians conduct follow-up telephone calls to
patients for a wide variety of data collection study needs including
intervening cardiovascular adverse events, cardiovascular procedures,
administration of quality of life and compliance questionnaires,
Imaging Core Laboratory
Services - CCS provides a full range of cardiovascular
imaging core laboratory services, supervised by leaders in cardiovascular
imaging, including radionuclide myocardial perfusion imaging, cardiac MRI, cardiac
ultrasound, hemodynamic monitoring, etc. Services include: imaging
protocol development, imaging manual, site selection and screening
for imaging capabilities, image transfer and translation, central
image analysis, as well as data analysis, interpretation, presentation
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