Leading Provider of Technology-Enabled Solutions for Clinical Research

Transcription

1 Leading Provider of Technology-Enabled Solutions for Clinical Research

2 SUCCESSFUL CLINICAL TRIALS REQUIRE THE ABILITY TO SEE KEY DETAILS AND UNCOVER HIDDEN INSIGHTS. utilizes science and technology to bring CLARITY to clinical trials: helping companies to develop new life-improving therapies more EFFICIENTLY and SAFELY. SERVICE SCIENCE FOCUS Not a traditional software company is a technology-enabled service provider. Solution development and service delivery are driven by unmatched scientific expertise. We work with sponsors and CROs across all industries, phases, and sizes. scales to the situation. 3

3 Clinical Trial Management System Electronic Data Capture & esource Randomization & Trial Supply Management App xchange Research Network Risk-Based Monitoring TECHNOLOGY- Y ENABLED SOLUTIONS TECHNOLOGY-ENABLED SOLUTIONS Medical Imaging Payments & Forecasting Pharmacovigilance Patient Recruitment Clinical Adjudication SCIENTIFICALLY-DRIVEN SERVICES Cardiac Safety BIOCLINICA OFFERS CAPABILITIES ACROSS THE TRIAL LIFECYCLE, SUPPORTED BY SCIENCE & TECHNOLOGY EXPERTISE s customers benefit from capabilities that leverage scientific, medical, and domain experts and advanced technology to help conduct clinical trials more efficiently and safely improving quality and outcomes. 5

4 PLAN STAGE (Quality by Design) Protocol Protocol Review Desk Research Network & Patient Recruitment Study feasibility Randomization & Trial Supply Management (RTSM) Optimized clinical supply plan Risk-Based Monitoring (RBM) Monitoring plan STUDY & SYSTEM STARTUP (risk identification & trial optimization) Research Network Investigator sites & management Patient Recruitment Global patient outreach RTSM Supply optimization and forecasting EDC Setup/build study RBM Setup study/site Key Risk Indicators (KRI) CTMS Setup study KRI s at program regional level Payments Set site & patient payment milestones Engage local patient communities Conduct targeted global outreach Centralized cardiac safety services Randomize patients & dispense drug Image submission, management, analysis, reporting & data transfer esource or sites enter data manually Flexible SDV/SDR Monitoring recommendations viewed as action items alerts sent to CRA s/study Manager etc. RACT data from EDC and CTMS sent to RBM EDC case report form and CTMS trigger clinical payments Review RBM KRI dashboards for risk & monitoring recommendations STUDY EXECUTION (risk management, data quality & operational efficiencies) Research Network Patient Recruitment Cardiac Safety RTSM Medical Imaging EDC Clinical Adjudication CTMS Lost to Follow-Up Payments RBM Database Lock Conduct study from global network of investigator sites Find and qualify patients local to investigator sites Analyze actuals against supply plan to reforecast and optimize Analyze patient data for unclean or missing data that could delay database lock Centralized, independent clinical event review Manage issues identified in document findings Recover patients lost to follow-up CRA conducts monitoring visit in CTMS according to plan (onsite/remote) & RBM recommends visit frequency ANALYSIS STUDY DISCLOSURE & POST-MARKET (risk reporting & pharmacovigilance) SAS programming, Biostatistics & other Data Management Services Pharmacovigilance Process and manage safety cases Post-Approval Research Ongoing & Final Analysis of RBM Plan to be used for future program/study level design (Quality by Design) Monitoring Plan & Updates Available for Review Documentation Action reports exported from RTSM/CTMS/EDC & RBM to include in clinical study report CLINICAL STUDY REPORT brings CLARITY, FOCUS, and FLEXIBILITY to meet your business needs throughout the clinical trial lifecycle. 7

5 Clinical trials are complex, and traditional solutions are either MONOLITHIC or FRAGMENTED. HOW BIOCLINICA IS DIFFERENT FROM TRADITIONAL SOLUTION PROVIDERS MONOLITHIC SOLUTIONS BIOCLINICA SOLUTION Inflexible vendors who force you to adapt to their systems. Partners with you to create the right configuration model for your trials. creates clarity in your clinical trial SO YOU CAN MAKE BETTER DECISIONS. FRAGMENTED SOLUTIONS Loosely connected systems from various vendors that obscure and isolate your data. BIOCLINICA SOLUTION Offers an agile technology-enabled services ecosystem with science at the core of every decision. 9

6 Hundreds of experienced scientific, medical, and domain experts bring unmatched insight ACROSS CLINICAL DEVELOPMENT, FROM THE INITIAL PROTOCOL TO POST-APPROVAL. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), s employees offer committed, detail-focused service through all stages of drug and device development. by the Numbers 400+ Clients Includes Top 100 Pharma & Top 10 CROs 166 Drugs Approved by the FDA Using Solutions 4,000+ Clinical Trials Supported 3,400+ Employees Worldwide 30+ Years of Experience Phase I-IV Expertise 11

7 Ready to bring clarity to your clinical trial? Visit bioclinica.com. bioclinica.com/contact BIOCLINICA SEE MORE CLEARLY V1JAN2018 CO_7005