Data Management & Biostatistic
Deliver accurate data for reliable clinical trial results

For a successfull clinical trial it is important to have a good data management system and collect accurate data as needed for your trial. Select the right system components tailored to project acquirements. Professional setup of your EDC system and train all neccessary stakeholder intensively. Moreover, it is important to continously clean the data to keep your records accurate and communicate with the study team.

Symbio Proinnovera delivers accurate data for reliable clinical trial results.

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EDC Solution – System in-use and Feature

We do support various systems and all of our systems do feature

Browser based EDC solution (no software installation required)
Compliant with FDA 21 CRF part 11
Combined eCRF, ePRO, IRT solution
Independently build and validate databases
Automated import of external data (e.g. Lab data)
Automated and customizable export of data
Interactive reports and task lists

Process – eCRF Implementation

eCRF Implementation

Setup of CRF development core team and eCRF roll-out plan

Early start of CRF design (CDISC CDASH)

Development of data transfer agreements with external data vendors

Full Data management documentation (DMP,DVP, UAT log…)

eCRF Implementation with user-friendly navigation


Setup of interfaces for external data import

Online check and notification programming

Setup of data export

Setup of auto-encoding tool

Configuration of user roles and query workflows

Programming of custom reports

Setup of eLearning for eCRF users

ePRO Workflow

ePRO Workflow

Integration of patient contact information

Patient identifying information is blinded to all other users

Patients receive notifications when data is expected

Form-level security controls access

Edit checks set allowable window for data entry

Data is immediately available in eCRF once ePRO is saved

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Our Services

We are a full-service CRO. We take this literally – whether you choose all or some of our service functions.