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.

BIOCLINICA CLINICAL DATA MANAGEMENT

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.

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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

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.

PLACE POWERFUL EDC TOOLS

AT YOUR FINGERTIPS

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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.

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DELIVERY MODELS

» Basic EDC: Bioclinica EDC license only

» Full Service EDC: Bioclinica EDC license plus

Clinical Data Management (CDM) Services

» Bioclinica EDC Technology Enablement: Study

build training support and library services

DEDICATED GLOBAL

EDC/DM TEAM

EXTENSIVE ONCOLOGY

TRIAL EXPERIENCE

2,000+ STUDY BUILDS

STUDY BUILD TURNAROUND TIME

48 hours – 5 weeks for repeat customers

8 - 12 weeks for new customers

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

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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.

VALUE-ADDED CAPABILITIES

ACCELERATE DATA CLEANING

AND IMPROVE DATA QUALITY

WITH BIOCLINICA’S CLEAN

PATIENT OPTICS (CP OPTICS)

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.

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.

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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.

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

THE BIOCLINICA CLINICAL

DATA MANAGEMENT

ADVANTAGE:

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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.

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Ready to bring clarity to your clinical trial? Visit bioclinica.com.

bioclinica.com/contact