ClinCapture the most advanced open source EDC


ClinCapture integrates with a suite of modules that perfectly complement your Electronic Data Capture (EDC) needs and extend your capabilities.

    Welcome to your eClinical Suite

 

ePRO

 

Randomization

 

CTMS

 

Offline

 

BioSpecimen Safety CDISC Reporting Offline

ePRO

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Empower your patients: ClinCapture features an integrated open source ePRO (Patient Reported Outcome) module. Intuitive and user-centered, this module allows seamless patient data collection to your Electronic Data Capture (EDC) system for your clinical study.

Deliver an intuitive experience: The ePRO module is remarkably simple to use. It has been designed to maximize the ease for patients to report their observations. It contains dynamic forms which reduce data entry time.

Benefit from seamless processes: The reported data is automatically and securely imported from the ePRO system directly into ClinCapture. If a patient doesn't fill the diary as expected, ClinCapture follows up with an automated email reminder to the patient. The ePRO module has proven to save time and money for our clients (read the case study). It can be implemented in just a few days, in order to start data collection quickly.

Developed by

 Clinovo

ClinCapture ePro

randomization

Randomization

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Advanced Randomization: ClinCapture  features a flexible, easy-to-use, and safe patient randomization module. It is the only open source Electronic Data Capture (EDC) with this capability. Clinovo has proven its technological leadership by providing randomization services in clinical studies up to 1,700 patients.

Ready-to-use: Developed in collaboration with Randomize.net, the randomization module allows you to randomize subjects in one single click. Based on your randomization protocol, ClinCapture’s development team will configure the system to make it ready-to-use and seamless for end-users. Randomized subjects can be automatically assigned to different treatments using Dynamic Groups.

Safe and compliant. The randomization function has been designed to perform its role efficiently and seamlessly while preserving data integrity and patient safety. Critical patient data is encrypted throughout the randomization workflow. Randomization time and results are securely logged in the study audit log to ensure 21 CFR Part 11 compliancy.

In partnership with

 Randomize.net

 

Randomization

CTMS

CTMS

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Collaboration made easy: ClinCapture integrates with Clinical Conductor™ Enterprise Clinical Trial Management System (CTMSand SimpleCTMS, the most collaborative CTMS available today, to offer a complementary CTMS module with ClinCaptureIt facilitates communication and essential information access for clinical teams. It delivers a global and real-time picture of your clinical trials' status.

Full control over your trial: The CTMS module provides tools that coordinate operational, financial, contractual and administrative activities. Built for provider networks, AMCsSMOsCROs and sponsors, it is essential for organizations managing multiple studies across multiple sites.

In partnership with

 BioOptronics

CTMS

offline

Offline

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Anytime, Anywhere: ClinCapture can be accessed in offline mode through a two-way integration with Ad Scientiam, the leading player in enterprise-class mobile data electronic forms. ClinCapture's new offline mode pushes back the frontier of Electronic Data Capture. Clinical data can now be entered anytime, anywhere. It is securely synced up with the database as soon as an internet connection is available.

New means of capturing data: Ad Scientiam's integration offers an unprecedented flexibility to capture, verify and communicate clinical data. ClinCapture is now compatible with tablets and digital pens to further reduce data entry time and improve data integrity. The use of digital pens proved in case studies to be up to 4x more accurate than web-based EDC. To meet regulatory requirements and protect your data integrity, the offline module is 21 CFR Part 11 compliant.

In partnership with

 Mi-Co

 

Offline

BioSpecimen

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Comprehensive BioSpecimen tracking solution: ClinCapture integrates with caTissue+, the enterprise-scale Biobanking Management System. As part of ClinCapture's eClinical suite, caTissue+ is a web-based biospecimen tracking application that allows you to track study participants, along with their consents and their biospecimens. Users can set up multiple banks within single caTissue instance and control privileges across banks.

In partnership with

 caTissue+

 

Biospecimen

safety

Safety

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Streamline your safety process: The Safety module is offered in partnership with Ennov Solutions, the Electronic Document Management & Business Process Management expert. The system is a turnkey, secure and validated web-based solution to accelerate the entry, assessment, and submission of adverse events (AE) and serious adverse events (SAE). Developed by Ennov, it can interact with ClinCapture through an automated and secured import/export function. The system provides a real-time global picture of the sanitary security level of your drug, medical device or diagnostic system.

Improve critical safety data quality: This integration streamlines your drug safety workflow by lowering the risk of data entry errors and duplicated data. The system has been designed to be perfectly intuitive for its end-users, further accelerating the safety data reporting process.

Compliant across borders: Fully 21 CFR Part 11 compliant, the safety module is up-to-date with the latest FDA requirements. It is also ICH XML E2B compliant to meet European's safety legislation.

In partnership with

 Ennov

 

Safety

CDISC

CDISC

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CDISC ODM ready: ClinCapture's extract data module natively produces CDISC Operation Data Model (ODM) XML datasets. The ODM is a CDISC standard which allows clinical systems to exchange data using XML (Extensible Mark-up Language). Clinovo developed SAS macros to enable the transformation of ClinCapture’s CDISC ODM datasets into SAS datasets automatically. Any SAS program that invokes these macros can access ClinCapture data as CDISC compliant SAS dataset.

Accelerated CDISC SDTM conversion: ClinCapture's extracted datasets can be automatically converted to Study Data Tabulation Model (SDTM) using CDISC Express, Clinovo's CDISC SDTM conversion tool. CDISC Express is a powerful SAS®-based mapping tool that streamlines and automates the SDTM data conversion process. CDISC Express follows the new SDTM 3.1.3 specifications, and includes the latest SDTM medical device domains released by the CDISC organization.

Developed by

 Clinovo

Clinovo is a trusted CDISC Registered Solutions Provider
and CDISC Gold Member.

CDISC RSPGold Member

 

Safety

 

 

 

 

 

 

 

 

reporting

Reporting

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Faster evidence-based decisions: Clinovo’s development team integrated ClinCapture with the open source Pentaho Business Intelligence system to deliver LiveReports on study metrics. It gives the capacity to principal investigators and managers to take corrective decisions based on real-time data better and faster than ever before. The reporting module increases your productivity and reactivity while protecting patients' safety by spotting issues faster and earlier. ClinCapture comes with  3 canned reports included at no cost. Additional reports are offered as a service.

Seamless integration: Your clinical data is seamlessly synchronized with the module to deliver real-time graphical reports on demand. With single sign on, ClinCapture's reporting module removes the burden of user and password management.

In partnership with

 Pentaho

 

Reporting

digitalpen

Reporting

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Simplifies data entry: ClinCapture was integrated with Popsicube, a leading provider of Digital Pen and Paper Technology for the clinical trials and pharmaceutical industries to recognize and capture handwritten information on paper forms.

Converts handwritten ink to digital data: As part of CinCapture’s eClinical Suite, Digital Pen is designed to recognize high-level handwritten data, and transferring it onto a digital-paper forms in a secure, encrypted format. 

 

In partnership with

Patient Profiles

 

Reporting

medicalcoding

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Official WHO Drug Certification

ClinCapture is the first Open Source Electronic Data Capture (EDC) system to receive the WHO Drug Dictionaries Medical Coding Certification by Uppsala Monitoring Center (UMC).

 

Improve clinical data consistency: Users are able to appropriately categorize medical terms entered in ClinCapture. A new role has been created in the system: 'Study Coder' who can only access the Medical Coding page to code or approve/adjudicate the medical terms that were previously coded. This new module of ClinCapture greatly improves clinical data consistency and interoperability

Rely on 4 medical dictionaries: The system supports multiple dictionaries, including WHO Drug, MedDRA, ICD9 and ICD10. Additional dictionaries can be easily supported upon request.

Save time with auto-coding: ClinCapture also supports auto-coding if a synonym already exists for a medical term.

 

In partnership with

 Patient Profiles

Medical Coding

 

 

Case Study 3

Case Study 2

Case Study 1

Case Study 4

Case Study 5

Case Study 6