BIOCLINICA CLINICAL DATA MANAGEMENT

Transcription

1 BIOCLINICA CLINICAL DATA MANAGEMENT Achieve faster speed to market, with Bioclinica s best-in-class Electronic Data Capture (EDC) technology and in-house full-service Data Management (DM) services.

2 $ BIOCLINICA IS DEDICATED TO HIGH-QUALITY DATA, AT FASTER SPEEDS AND WITH LOWER COST. Lengthy EDC builds and inadequate data management delay both study start-up and database lock. Clinical data management is a complex, mostly inefficient process, especially with complex protocols, adaptive trial designs, global trials and regulatory compliance requirements. This can lead to lengthy EDC builds that are cumbersome and difficult to change once the study commences. A lack of clinical data management resources and therapeutic area expertise contribute to systems and processes that don t quite meet the needs of the study or regulatory requirements.

3 SEE DEEPER INTO YOUR STUDIES AND MANAGE STUDY DATA, NOT JUST CAPTURE IT. CREATE THE RIGHT SOLUTION THROUGH OUR INTERACTIVE STUDY BUILD PROCESS ENABLE HIGHER QUALITY DATA THAT IS SCALABLE WITH STUDY NEEDS MINIMIZE STUDY RISKS WITH 100% CONTINUOUS QUALITY CHECKS ACHIEVE FASTER SPEED TO MARKET RECEIVE REAL-TIME STUDY UPDATES 3

4 PLACE POWERFUL EDC TOOLS AT YOUR FINGERTIPS Bioclinica s EDC is an integrated esource solution, allowing the clinical data capture, management and analysis as it is being collected, giving early visibility into and real-time updates for studies of any size, phase or complexity. Data collection right at the source not only eliminates paper but also reduces source data verification (SDV), while serving as an indisputable esource record for regulatory authorities.

5 Easily integrate Bioclinica as well as non-bioclinica products, including IRT, CTMS, laboratory vendors, epro and mobile health technologies. Integrated imaging capabilities allow visibility into image status. DEDICATED GLOBAL EDC/DM TEAM DELIVERY MODELS» Basic EDC: Bioclinica EDC license only» Full Service EDC: Bioclinica EDC license plus Clinical Data Management (CDM) Services 2,000+ STUDY BUILDS» Bioclinica EDC Technology Enablement: Study build training support and library services EXTENSIVE ONCOLOGY TRIAL EXPERIENCE STUDY BUILD TURNAROUND TIME 48 hours 5 weeks for repeat customers 8-12 weeks for new customers 5

6 BIOCLINICA OFFERS FULL-SERVICE, FLEXIBLE, GLOBAL CLINICAL DATA MANAGEMENT SERVICES We have experienced DMs across all therapeutic areas and global time zones as well as in-house biostatisticians to help:» Keep up with evolving industry and regulatory requirements» Scale resources when there is a lack of internal expertise in specific therapeutic areas» Manage outsourced partners or DM services

7 VALUE-ADDED CAPABILITIES RAPID STUDY BUILD Save time using study build and ecrf libraries. PARTNERSHIP APPROACH Work closely with our SAS programming team for comprehensive, quality support that can scale to your study and your own team s needs. EASIER CHANGE MANAGEMENT Deploy changes at a click of a button and without disruption to the study, even complicated mid-study changes. Accomplish in minutes what others measure in work days. STANDARDS COMPLIANCE Take advantage of our early, full adoption of CDISC ODM standards. QUALITY ASSURANCE Minimize study risks with 100% continuous quality checks. CLOUD TRANSFORMATION GATEWAY Integrate seamlessly across Bioclinica s platform as well as third-party applications (e.g., mobile health technologies, IRT, CTMS, lab vendors, epro). AUTO-ENCODER Eliminate drug classification errors with direct integration with the EDC. ADHERENCE TO REGULATORY GUIDELINES The robust system meets all regulatory guidelines and conventions, including 21 CFR Part 11 and ICH-GCP. 7

8 ACCELERATE DATA CLEANING AND IMPROVE DATA QUALITY WITH BIOCLINICA S CLEAN PATIENT OPTICS (CP OPTICS) With the powerful data visualization tools in CP Optics, uncover patterns about the status of internal AND external patient data to the EDC system for early identification of potential study problems. Data quality and completeness in clinical trials are important concerns for sponsors, CROs and regulatory agencies alike to ensure appropriate evaluation of the drug s/ device s efficacy and safety. Although clean patient data status is one component of ensuring data quality, the amount of data to review and reconcile across all study sites and patients can be daunting. Without the ability to track the status of tasks to bring patients to clean status, study teams are unaware of patient status and the remaining key tasks to achieve database lock.

9 With Clean Patient Optics (CP Optics):» Get answers about the overall study health and team progress toward the goal of database lock.» See at a glance if a patient has reached the end of the study and any remaining data activities.» Easily spot missing pages or visits, data to be reconciled, terms to be medically coded and pages to be SDVed. 9

10 THE BIOCLINICA CLINICAL DATA MANAGEMENT ADVANTAGE: Reduce trial and submission risks with faster collection and analysis of preliminary data Deliver high-quality data faster and at lower cost Accelerate the speed of data management Achieve a clean study database lock provided by end-to-end study delivery: study database, database management, medical coding, standard data tabulation model (SDTM) and tables, listings & figures (TLF) Minimize study risks

11 Bioclinica s CDM encompasses best-in-class Electronic Data Capture (EDC) technology and in-house full-service Data Management (DM) services at cost effective prices, facilitating faster speed to market. Whether you are a data manager, site investigator, monitor or member of the operations group, Bioclinica provides all the essential tools each tailored to the individual user. 11

12 Ready to bring clarity to your clinical trial? Visit bioclinica.com. bioclinica.com/contact V1MAY2018 MIT_1003