EDC & DATA MANAGEMENT SERVICES

Our Serviceswww.evomind-edc.com

EDC Solution Hosting

EDC Activities

EDC Data Entry

EDC User Training

EDC SOP Library

EDC Project Management

Our Expertise

Our EDC Solution

Our Services - Introduction

We offer services focused on the OpenClinica Open Source EDC solution

At EVOMIND we are passionate about Free & Open Source Software thus we consider OpenClinica® to be an excellent platform for conducting EDC activities while reducing the overall costs of

implementing a Clinical Study by standard means.

Our services include end to end data management services for Clinical Studies with OpenClinica.

We offer our own hosted installation of the OpenClinica Community Edition, eCRF design, testing & support, exporting Clinical Study data, dedicated trainings for OpenClinica and a customized SOP

library for improving a Clinical Study workflow with OpenClinica.

EDC Solution Hosting

EDC Solution Hosting - Technical Specs

INTEL XEON CPU (Haswell Architecture)

4GB of ECC RAM

2 x 1TB Hard-drives in a RAID1 setup

Linux CENTOS 6.5 Server Operating System

Local file-system encryption

SSL certificate for secured login

Firewall with specific rules

Monitoring system with blocking capabilities

Secured OpenVPN connection to the server

The OpenClinica EDC Solution is hosted on a dedicated server

EDC Activities

eCRF Design

Clinical Study Setup

EDC user administration

EDC Data Management

EDC User Training

EDC Activities - eCRF Design

Multiple data fields - drop down lists, text area, calendar picker, radio buttons etc.

Different Clinical Study Events - each Clinical Study Event is implemented in OpenClinica with its own eCRF

Different eCRFs versions - several versions of eCRFs can be implemented per Clinical Study Event

Multiple eCRF rules - hide sections of the eCRFs until a certain user action, send email notifications when a specific event occurs, block eCRF saving until the user corrects a value etc.

eCRF layout options - the eCRF can be organized in sections and subsections with different colors that can help in increasing the awareness of the user when they fill in the medical data

The OpenClinica EDC Solution allows a flexible eCRF design approach

EDC Activities - Clinical Study Setup

Create Study 1 Create CRF 2 Create Event Definitions 3 Create Subject Group

Classes 4

Create Rules 5 Create Sites 6 Assign Users 7

The OpenClinica EDC Solution has a predefined Clinical Study Setup workflow

EDC Activities - Clinical Study Setup Create Study 1

Create Study section contains all the relevant information for the Clinical Study setup

Setup the following information:

❏ Protocol ID❏ Clinical Study Title❏ Clinical Study Summary❏ Principal Investigator❏ Sponsor❏ Protocol Type❏ Eligibility Conditions❏ Facility Information❏ Study Parameter Configuration❏ Other information

EDC Activities - Clinical Study Setup 1

Create CRF section allows the upload of the eCRF template created in an Excel format

Create CRF 2

EDC Activities - Clinical Study Setup 1

Create Event Definitions section allows the creation of the Clinical Study events per the medical Protocol requirements

Create Event Definitions 3

Study Events can be created as per the medical Protocol:

❏ Scheduled events - e.g. visits❏ Unscheduled events - e.g. Adverse Events

Events that are scheduled can be set to repeat; e.g. after the PI fills in the Visit 1 eCRF the system will allocate to the subject the Visit 2 eCRF and will ask the user for the date.

EDC Activities - Clinical Study Setup 1

Create Subject Group Classes section allows the creation of subject Groups within the Clinical Study

Create Subject Group Classes4

Subject Group Classes can be used to organize the Clinical Study subjects with specific treatment options, with the category of age etc.

EDC Activities - Clinical Study Setup 1

Create Rules section allows the creation of subject Groups within the Clinical Study

Create Rules 5

Create Rules section allows for the upload of the Rules template file in the Clinical Study.

Rules allows for advanced functionality to be added to the EDC workflow, which can impact positively the data quality of the medical data collected during the Clinical Study.

Specific rules can specific behaviour of the eCRF based on the user interaction, cross-check for quality of the data entered or creating real-time email warnings when certain events or options are triggered in the eCRF.

EDC Activities - Clinical Study Setup 1

Example of a Rule - certain areas of the eCRF can be hidden until the user chooses a certain option - e.g. “Yes”

Create Rules 5

EDC Activities - Clinical Study Setup 1

Create Sites section allows the creation of Sites within the Clinical Study

Create Sites 6

Create Sites section allows the creation of Clinical Study Sites.

OpenClinica requires at least one Clinical Study Site to be created in the Clinical Study Setup workflow.

Each site can be assigned an unique Protocol ID, a target for enrollment, a Principal Investigator, information regarding the specific location - address, telephone, email address, as well as a start and end date for the Clinical Study enrollment.

EDC Activities - Clinical Study Setup 1

Assign Users section allows to add users to the Clinical Study

Assign Users 7

Users can be assigned to the Clinical Study in OpenClinica at two levels:

1. Clinical Site level - this usually includes roles as Monitor, Investigator, Clinical Research Coordinator

2. Clinical Study level - this can include the Data Manager, Study Director, Monitor, Data Entry Person

EDC Activities - EDC User Administration

The OpenClinica EDC Solution has predefined user roles & user types

User Type 1 User Role 2 User Level 3 User Permissions 4

Two main user types are allowed in OpenClinica

● Regular user● Business admin

user● Technical admin

user

Each category constrains what each user can do and have access in the EDC application

❏ Study Director❏ Data Manager❏ Investigator❏ Monitor❏ Clinical

Research Coordinator

❏ Data Entry Person

❏ Data Specialist

Users can be assigned to 2 different levels:

1. Clinical Site level

2. Clinical Study level

User permissions are setup based on the user type, the user roles and the user level.

EDC Activities - Data Management

OpenClinica allows for several data export formats: SPSS, CDISC, XML, Web, Text and Excel

End-to-end management of clinical data collected using the EDC solution

End-to-end management of electronic data collected using the EDC solution and transferring the electronic data into a format that would allow statistical analysis to be conducted as per the protocol requirements.

EDC Data Entry

EDC Data Entry

For specific requests we can accommodate data entry for Clinical Study Projects for which “paper CRFs” were used to collect the medical data.

OpenClinica has a double-entry system integrated and allows data entry activities based on “paper CRFs” as a source document - e.g. page numbers etc.

This approach can increase the data quality and can reduce the error rate compared with manual processing in an Excel table format.

The final output can be exported in SPSS or any other format supported by OpenClinica.

For Data Entry purposes we are using the OpenClinica EDC solution

EDC User Training

EDC User Training

We have developed Training Packages focused on the Clinical Study workflow in OpenClinica.

We can train: Monitor users, Investigator/Clinical Research Coordinator users and we also offer an advanced training package for Data Managers.

We developed training packages specific for the OpenClinica EDC Solution

EDC SOP Library

EDC SOP Library

The OpenClinica study workflow requires specific SOP (Standard Operating Procedures) to be developed and implemented, taking into consideration the EDC solution specifics.

Our EDC SOP Library consists of:

1. SOP-EDC CRF Design2. SOP-EDC Roles & Responsibilities3. SOP-EDC Backup & Recovery4. SOP-EDC Query Management5. SOP-EDC System Maintenance6. SOP-EDC System Security7. SOP-EDC System Setup8. SOP-EDC System User Training

We developed SOPs specific for the OpenClinica EDC Solution

EDC Project Management

EDC Project Management

If requested we can offer Project Management services for the EDC solution and the Clinical Studies performed with the OpenClinica application.

We have a PMP (Project Management Professional) Project Manager certified with Project Management Institute (PMI) since 2012.

We are using the PMI methodology and we can accommodate both classic “waterfall” projects as well as “agile” projects.

We offer Project Management services for the OpenClinica EDC Solution

Our Expertise

Catalina EnescuData Manager role in OpenClinica; Catalina has extended experience as an IT Architect and IT instructor; Catalina’s advanced programming skills include C++, JAVA, HTML5 & CSS3, PHP, MySQL, Oracle SQL & PL/SQL. Catalina has a master’s degree in Computer Science – database programming and over 8 years experience in complex IT environments. Catalina is currently studying to get a degree in advanced biostatistics programming.

Responsibilities in the OpenClinica Community Edition – EDC

solution include:

❏ eCRF design❏ eCRF implementation❏ Rule design❏ Rule implementation❏ eCRF testing❏ Data quality control❏ Technical support for CRF & CRF rules❏ Data export support❏ Data Manager role in OpenClinica – oversees the quality

control of the data collected with the EDC solution and coordinates the eCRF design activities

❏ Technical support for the PostgreSQL database❏ Technical reviewer for the EDC SOPs and Operating

Manual

PMP “Project Management Professional” – PMI Certification since 2012. Administrator for OpenClinica; Razvan’s responsibilities include server setup and maintenance, security policies, and overall administration of the clinical studies; Razvan has extensive project management experience – 4 years experience in Clinical Studies and 5 years experience in IT.

Responsibilities in the OpenClinica Community Edition – EDC solution include:

❏ Clinical Study setup – users, sites, standard parameters etc.

❏ Overall user administration – OpenClinica and OpenVPN❏ Study Director role in OpenClinica – oversight of the

Clinical Study project in OpenClinica Community Edition❏ Functionality testing for the eCRF❏ Technical support OpenClinica server and OpenVPN server❏ Creator, owner and maintainer for the Standard Operating

Procedures for the Clinical Study Workflow implemented with OpenClinica Community Edition

❏ Creator, owner and maintainer of the OpenClinica Operating Manual – designed specifically for OpenClinica main user types

Razvan Enescu

Our EDC Solution

Our EDC Solution

EVOMIND DEV EDC solution is based on the OpenClinica® Community Edition – an Open Source Clinical Trial software for Electronic Data Capture. OpenClinica® offers an alternative to the vendor locked-in created by other Commercial EDC Closed Source solutions. OpenClinica® gives the necessary freedom to it’s users to tailor and adapt the EDC solution to their needs.

Our EDC solution is OpenClinica Community Edition; for more details access http://www.evomind-edc.com/edc-solution/

Our EDC Solution - Useful Links

OpenClinica DEMO https://www.openclinica.com/home/openclinica-demos/-edc.com/edc-solution/

OpenSourcehttps://www.openclinica.com/open-source-clinical-trial-software/

OpenClinica User Documentationhttps://docs.openclinica.com/

OpenClinica FAQhttps://www.openclinica.com/faq-openclinica/