ClinSearch EDC Systems

ClinSearch EDC Systems

2015

2

The Challenges of EDC

Insufficient expertise creating data validation plans

ClinSearch has extensive experience creating validation plans and an expert in -house team

Miscommunication between sponsor and vendor regarding expectations and capabilities

At ClinSearch, you will have a dedicated account manager and project manager assisting you at all t ime

Initial set-up costs

Offset by significant savings in the long run.

Challenges 2015

3

The Advantages of ClinSearch’s EDC

Customization of electronic case report forms (eCRFs)

Web-based platform , providing access for sites to enter data

Cleaning and locking process on-the-go, in which any queries against the data are resolved at entry

Adaptation of the f inal data to SAS datasets

Cost advantage .

Advantages 2015

Prompt start-up

Prompt database lock

Clean data

High level of

harmonization

High grade of control

Sharp data

management

Finer trial assessment

Lower risk of error

4

Our Expertise:

Developing Data Validation Plan

The setting up of a new EDC system involves the application of all

expertise available in-house:

The IT team works closely together with the data management

department and the project directors; the research associates are

regularly and widely involved in the testing routine for usability and

troubleshooting.

This ensures that the tool delivered to the client will provide a spotless

result and the best possible quality of data.

Data Validation 2015

5

Our Expertise:

User Training and Management

Users’ access can only be

provided after proper

training

Access privi leges vary

according to study function

and are determined by the

sponsor.

This minimizes the potential for

errors and protects data integrity.

User training 2015

6

Our Expertise:

Visual Implementation of Site Data

Helps CRAs follow site

status, new patient

enrolment, or lagging

recruitment rates

Customizable, can be

adapted for display of any

kind of data collected.

This tool lets CRAs effortlessly

keep track of the sites creating

more accountability.

Visual implementation 2015

7

Our Expertise:

Creating Alerts

Alerts 2015

New pat ient enrol led

New AE declared

This tool aids CRAs to prioritize and manage their work more efficienty.

8

Our Expertise:

Data Cleaning and Locking On-the-Go

Data cleaning 2015

Queries are automatically generated

based on the approved validation

plan

Manual queries can be generated by

a CRA on a monitoring visit , then

tracked via a report, thus creating a

direct and immediate means of

communication and correction with

the study team.

This tool al lows for the immediate resolve of queries, yielding data

free of errors and ready for statistical analysis.

9

Our Expertise:

Data Reports

Data reports 2015

Automatically generated by the

system

Customizable – according to the

client’s demands, specif ic sets of

data can be extracted for regular

status reports (e.g., weekly AEs

report, monthly patients’ fol low-up

report, etc.)

This tool al lows for the immediate resolve of queries, yielding

data free of errors and ready for statist ical analysis.

10

Our Expertise:

Data Safety and Repository Function

Data safety 2015

At each data entry session, data is

synchronized with either ClinSearch’s

or the Sponsor ’s internal servers

A SSL-protected domain is used for the

EDC setup – all informations exchange

between EDC and the servers wil l be

encrypted

All crit ical study documents are

available for site to download

reducing print costs and paper waste.

11

Our Expertise:

MedDRA Coding

MedDRA 2015

MedDRA is the industry-

standard ICH product for the

communication of cl inical

information

Use of MedDRA allows

information exchange and

analysis among many partners in

an eff icient manner with

accuracy and reproducibil i ty,

conveying a high-end product.

Contacts

For France:Stephanie Dousa-Callier, Business Development ManagerPhone: +33 1 47 35 13 57 Mob: +33 6 64 46 31 [email protected]

International:Ivelina Georgieva, International Key Account ManagerMob: +420 702 133 [email protected]

Contacts 201516