CCS Sponsor Services:

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.

Protocol 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 without re-submission.

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.

Trial 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.

Centralized 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.

Centralized 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.

Central Regulatory 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.

Clinical 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.

Investigator 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.

Data Interpretation/Presentation/Publication - 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 may arise.

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 members.

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 all meetings.

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.

Safety Reporting - 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, etc.

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 and publication.

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