CLINICAL DEVELOPMENT SERVICES
PROTOCOL DEVELOPMENT - Working directly with a sponsor's senior staff, CCSF will either advise sponsors in protocol design and determination of end points, or develop and write the protocol for the sponsor depending on needs. CCSF employs an iterative process with interactive scrutiny from thought leaders, seasoned operations staff, and statisticians providing input on endpoints, study design and inclusion/exclusion criteria. This interdisciplinary process integrates regulatory, operational, and clinical input over a process that maximizes chances of initial acceptance by the FDA, and minimizes time from design to first patient in. Back to top.
INFORMED CONSENT DEVELOPMENT - Consistent with FDA and HIPAA guidelines, CCSF 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 CCSF sites regarding changes that may be required by local or central IRBs. Back to top.
TRIAL BUDGET PREPARATION - CCSF 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. Back to top.
CENTRALIZED SITE SELECTION - Utilizing the CCSF Investigator Database Application which includes rich data on study performance metrics together with our intimate understanding of investigative sites, CCSF can identify those sites that have direct experience/expertise that matches the sponsor's requirements for a particular trial. Back to top.
CENTRALIZED SITE CONTRACTING - CCSF 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. Back to top.
CENTRAL REGULATORY DOCUMENT COLLECTION & REVIEW - CCSF 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 CCSF 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, CCSF selects sites with central IRBs from the Investigator Database whenever appropriate for the study. Back to top.
CLINICAL ECONOMIC ANALYSIS - CCSF 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 CCSF’s approach to economic analysis is the integration of CCSF’s deep clinical expertise with respect to protocol and study design with sophisticated economic modeling expertise. CCSF 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. CCSF 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. Back to top.
INVESTIGATOR MEETING ACADEMIC SUPPORT - CCSF cardiovascular clinician thought leaders provide direction and input into academic meeting planning, presentations, and investigator relations. CCSF project managers are experienced in the logistics of academic meeting planning. Back to top.
SITE MANAGEMENT - Recognizing the critical importance of reaching enrollment targets in a steady fashion, CCSF 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 CCSF 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, CCSF 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. Back to top.
DATA INTERPRETATION, PRESENTATION & PUBLICATION - CCSF's cardiovascular thought leaders and clinical staff participate in the preparation of abstracts for presentation at major meetings and write articles for publication. See how our faculty can credibly publish study results in the thought leader library or go back to top.
MEDICAL MONITORING - CCSF 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. Back to top.
CARDIOVASCULAR EVENT ADJUDICATION - CCSF's 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 CCSF process also involves committee member identification, determination of appropriate supportive documentation and management of committee members. Back to top.
ADVISORY BOARD, STEERING COMMITTEE, & DSMB – CCSF is experienced in developing/managing advisory boards, DSMBs and steering committees for oversight of clinical trials. CCSF professionals develop committee charters, contract with committee members, facilitate timely payment of members, and manage all meetings. Back to top.
DATA MANAGEMENT - CCSF provides both electronic data capture (EDC) and paper-based data management services. CCSF has developed a low cost EDC data management application for registry and phase IV trials. CCSF 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. Back to top.
SITE MONITORING - CCSF CRAs are experienced in cardiovascular trials and geographically dispersed. Site monitoring in fully integrated into CCSF’s site management model. CCSF project managers train CRAs and sites on CRF/eCRF guidelines, protocol implementation, and local study coordination issues. CCSF has a quality assurance program for auditing CRAs and sites. Back to top.
SAFETY REPORTING - CCSF cardiac nurse clinicians review adverse events and prepare SAE reports to sponsors and regulatory authorities. Given the strong clinical credentials of its staff, CCSF is well positioned to assist sponsors in post marketing pharmacovigilance studies and data registries. Back to top.
PATIENT CALL CENTER - CCSF 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. Back to top.
CARDIOVASCULAR CORE LABORATORY SERVICES - CCSF's fully integrated core lab service offering streamlines the acquisition and analysis of data from imaging and hemodynamic assessments. Whether echo, SPECT, MRI, or hemodynamics, our specialized sites and hands-on thought leadership deliver results.. Back to top.