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ClinCapture

ClinCapture is the only validated electronic data capture software, available for free. As a leading cloud-based eClinical software, ClinCapture empowers CROs, Pharmaceuticals and Medical Device companies to build their studies themselves, lower their clinical trials costs and streamline their data capture processes. ClinCapture is headquartered in the Silicon Valley.

Homepage: ClinCapture

Description

ClinCapture is an eClinical software company that was founded in 2003 with the vision that it could disrupt and improve Clinical Trials through the use of open source software and collaborative development methods. With most clinical trials and medical research being done either on paper or with old fashioned software, ClinCapture bet on an agile approach that would provide researchers with the tools to leveraging eClinical technologies to run clinical trials more effectively. ClinCapture has proven that its technologies can substantially improve their research capabilities while lowering their costs and bringing medical innovations faster to market. ClinCapture is headquartered in San Francisco, CA, with offices in Salt Lake City, UT, and Ukraine.

While its origins were as an SAS consulting firm, ClinCapture grew organically to become the world’s a leading Electronic Data Capture (EDC) vendor. The company developed Clinical Data Management, Biometrics, and Staffing capabilities, over time and it is now primarily focused on developing its EDC system, ClinCapture, to meet the growing needs of small- to mid-sized biotech companies and Clinical Research Organizations (CROs)  to quickly start and run clinical studies.

About The ClinCapture EDC System

ClinCapture is the only validated Electronic Data Capture (EDC) software, available for free. Its leading cloud-based eClinical software empowers CROs, Pharmaceutical companies, as well as  Medical Device companies, to build their studies themselves, lower their clinical trials costs and streamline their data capture processes.

ClinCapture provides all the tools that small and mid-sized biotech companies and CROs need to develop and run clinical studies on their own. ClinCapture replaces both traditional EDC systems and paper-based solutions. The system includes a self-service platform that allows users to build and manage their own clinical studies. ClinCapture removes IT dependency to build databases, CRFs, and studies. ClinCapture meets clinical research and regulatory requirements while providing its users with significant savings compared to existing solutions in the industry.

From Open Source to The Cloud

One of the core reasons behind the success of ClinCapture is its open source roots. From day one ClinCapture has been an adopter and proponent of open source technologies. Open source software gives a greater number of pharmaceutical, medical device, and biotech companies, greater access to access to clinical systems. The code is available for them to modify and customize, as well as to improve. As a result  ClinCapture has been constantly enhanced by the internal company team as well a global community of more than 1,500 users and developers. In 2014, ClinCapture pivoted to port its EDC system to the cloud and launched the on-demand, self-service portal to create, launch, and manage studies without the need for a local IT infrastructure.

ClinCapture: Disrupting EDC in the Cloud

ClinCapture’s move to the cloud is the next major disruption in the EDC market. Currently ClinCapture is the only free cloud-based, 21 CFR part 11 and EU Annex 11 compliant, EDC system. Title 21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. European Union (EU) Annex 11 covers the interpretation of the principles and guidelines of GMP-regulated activities to computer systems in Europe.

ClinCapture addresses the traditional EDC pain points:

  • ClinCapture follows a freemium model allowing an initial license free, low cost EDC implementation. The users can then choose a “pay-as-you-go” model as the clinical trial progresses.
  • ClinCapture provides an intuitive drag-and-drop interface enabling clinical trial professionals to build and manage studies, thus removing the need for costly programming services.
  • ClinCapture hosts a secure, dedicated private cloud infrastructure that provides an immediate turn-key solution. This removes the dependency for in-house IT services while being fully compliant with FDA regulations.

1) The freemium model

ClinCapture is a “freemium” EDC system. It offers a basic free clinical study package (a basic set of features) and two paid packages (with a tiered pricing based on usage).  Users first select a study package depending on the level of features

2) Do-it-yourself study build

ClinCapture allows any clinical trial professional who is proficient with Microsoft Office products to build their own study. By removing their dependency on programmers, clinical researchers can retain full control for their study implementation, timelines and budget. ClinCapture Build Studio provides a drag-and-drop interface that includes the ability to:

  • Create, deploy, share and manage studies
  • Create and publish electronic Case Report Forms
  • Create and test edit checks
  • Create and manage forms libraries

3) A 21 CFR part 11 and EU Annex 11 compliant  hosting environment

To meet regulatory requirement and quality standards in the United States, ClinCapture’s freemium service requires a validated, HIPAA-compliant hosting environment as well as a sophisticated role-based EDC system. ClinCapture was validated using the Hybrid model that combines both the developer and end-user validation requirements. The system is validated following a “14-step hybrid validation model” based on risk analysis recommended by David Nettleton, one of the nation’s foremost experts on Computer System Validation (CSV) for 21 CFR Part 11.

Benefits of Using ClinCapture

There are multiple benefits to using ClinCapture. These include:

  • Speed of Implementation
  • Autonomy and user empowerment
  • Ability to Scale Up (Or Down) Quickly
  • Lower Cost of Adoption

1) Speed of Implementation

ClinCapture features a do-it-yourself platform and intuitive drag-and-drop tools to build a study.  These build tools, referred to as “studios,” allow a data manager to build a study in a matter of days, without any programming experience. Providence Medical was able to build CRFs and deploy the study database in one week. The following week, they trained the sites and started collecting the data. Compared to an average 6 to 8 weeks for a database build, ClinCapture enabled this sponsor to save 4 to 6 weeks.

2) Autonomy and user empowerment

Switching from paper to EDC requires profound changes on the organization, workflows, SOPs and forms, which are a major deterrent to adoption. For example, CRFs must be redesigned, taking into account dynamic forms and new data entry workflows. Traditional EDC systems require programming and IT skills to build a study and have a steep learning curve for all end-users.

In ClinCapture, clinical professionals can build their own database and do so much faster than in traditional EDC systems. This IT disintermediation transfers the power and control into the hands of the study builders; they can configure and deploy their studies without dependencies on anyone else.

A self-service model implies that onsite trainings are obsolete. Users learn how to use the system on their own, without relying on the EDC vendor. “Prior to using ClinCapture I was new to EDC, having no programming and little data management experience,” explains Jon Lyons, Clinical Operations Manager at Providence Medical Technology. “We were impressed how quickly we were able to begin data collection. The ease-of-use of the EDC platform ClinCapture really helped with a fast start,” says Jon.

ClinCapture Build Studio was designed from the ground up to address these market needs:

  • ClinCapture provides a turn-key solution, and users can start building their studies on their own, immediately after they register.
  • A drag-and-drop interface allows clinical data managers to build their studies without dependencies on EDC programmers or IT.  
  • The pay-as-you-go model accommodates any budgets (the startup package is free).
  • The EDC build process is streamlined.  For example, there is no need to create CRF mockups in Word to be implemented and tested by EDC programmers.  “Forms Studio” is easier to use than Word to design a CRF.  Forms Studio allows for online review by the sponsor and sites users. And once a CRF is designed, the CRF already implemented in the database!

Another client of ClinCapture, DigitalizaTXT, was using Excel files to tabulate data from paper source documents. Once they adopted ClinCapture Build Studio, study builds became fast, simple, and did not require any specialized programming skills.

3) Ability to Scale Up (Or Down) Quickly

One of the key characteristics of the cloud is “rapid elasticity”. It refers to the ability of a cloud service to scale on demand. Resources such as CPU cycles, memory, storage and network bandwidth can be provisioned instantly and scaled down when no longer needed.

For example, our cloud-based EDC system can automatically support an increase in study size, or provision additional servers when the demand grows. A mid-study size increase is seamless and doesn’t affect performance. In traditional EDC systems, there is a concern as to whether a server can handle workload increases without changing the physical infrastructure, which usually leads to delays and additional costs.

4) Lower Cost of Adoption

By moving away from Excel files to ClinCapture, the time and cost savings were significant.  DigitalizaTXT estimates 40% cost savings compared to paper and 70% time acceleration for data collection and cleaning. Another cause for cost increase using paper is the quality of the data entered on paper CRFs as there is no validation possible at the time of entry.  As a result, more queries are raised on paper studies, which introduces another source of delays and costs.

Using “Rules Studio,” complex edit checks can be created using an intuitive drag-and-drop interface.  Edit checks validate the data as it is entered, thus improving data quality and reducing queries.  The queries are resolved faster in ClinCapture, as the CRC and the monitor can look at the query and the data online without incurring expensive travel costs. 

In some traditional EDC systems, a significant amount of time and resources goes into the maintenance and management of the IT infrastructure.  One of the benefits of cloud-based services is to eliminate this overhead. 

ClinCapture CRO Partnership Program

The CRO Partner Program is designed to help CROs expand their service offerings, decrease internal costs, and win more business. ClinCapture's CRO Program offers resources and benefits including:

  • Full Sales Support: Including demo support, RFP support, and dedicated marketing materials.
  • Marketing Activities: Presence on ClinCapture website, joint press releases, and emailing campaigns.
  • Lead Generation: Providing CROs access to new business opportunities.
  • Special Partner Pricing: Allowing CROs to decrease costs with volume discounts.

CROs realize the strategic value of our CRO Program as it helps them complement their offering and drive business transformation. ClinCapture enables CROs to increase their profit margins while retaining more control over the services provided to sponsors and clinical trials. CROs can significantly decrease their time to build their clinical database and manage electronic case report forms (CRFs).

Examples of CRO Partners Around The Globe

ClinCapture's CRO partners are now present in the United States, Russia, Spain, Mexico, India and Japan.

  • Synergy Research Group is a full-service Contract Research Organization (CRO) based in Russia and founded in 2002 that delivers its Troika Promise of Speed, Cost and Quality to clients. Synergy provides a full range of CRO services to help global pharmaceutical and biotechnology companies conduct successful and cost-effective clinical trials. The company provides transparency, access and control to sponsors during the entire project through its cloud-based monitoring system. “ClinCapture allows us to deliver even higher levels of quality, savings and speed to clients” - Igor Stefanov, CEO of Synergy Research Group, Russia
  • L Data Science provides Clinical Data Management and Statistical services to life science companies in Japan. The company was founded by Dr. Yukiharu Yamaguchi in 2008 to accelerate innovation in the drug development industry.
  • Phoenix Clinical Research is a regional dynamic Clinical Research Organization (CRO) covering the Middle East and North Africa region. Phoenix CR is specialized in Medical Writing, Regulatory Activities, Monitoring, Project Management, Translation, Biostatistics and Electronic Software Solutions for Pharmaceutical and Biotechnology Companies and Hospitals.  Phoenix CR is also specialized in electronic software solutions and provides eCRF solutions, electronic libraries installation and electronic platforms for hospitals. Phoenix CR is proud to provide you with an innovative eCRF solution (ePhoenix®) compliant with 21 CFR Part 11 regulations.
  • Digitaliza TXT is an IT Consulting company that provides integration, development, training and infrastructure services. Digitaliza provides high value data services for CROs and clinical research companies in the region of México and Latin America. In the Latin American region, many clinical studies are still conducted using paper-collection methods instead of Electronic Data Capture (EDC). EDC adoption leads to significant reduction in data entry errors, speeds up data entry and query management and enables early identification of discrepancies or data entry errors, minimizing the time spent by monitors at sites. EDC systems provide real-time alerts and reports, giving decision makers instant access to critical data in order to more proactive in identifying bottlenecks such as late enrollment, and to be more reactive to data to ensure patient safety. According to Ana Pulido Ferrer, CEO of Digitaliza TXT, “We can rely on ClinCapture to fully support the solution and respond to any IT infrastructure needs which frees us up to focus on our core clinical service offerings." - 

Review our network of partners at http://www.clincapture.com/cro-program/cro-partners

ClinCapture and CDISC Standards

ClinCapture has always been a strong supporter of open source, web 2.0 technologies and global standards to accelerate clinical trials. In particular, ClinCapture is a strong advocate of CDISC Standards. ClinCapture is a trusted CDISC Registered Solutions Provider by the Clinical Data Interchange Standards Consortium (CDISC) organization. ClinCapture was also Gold Member of the CDISC organization for several years.

ClinCapture developed CDISC Express, a powerful SAS®-based system that automatically converts clinical data into SDTM. CDISC Express is a software developed to help advanced SAS Programmers accelerate the conversion to CDISC standards.

Ale Gicqueau, President & Chairman at ClinCapture president CDISC Express at PharmaSUG and several major conferences. He spoke at the at the CDISC Interchange Europe 2014 Conference in Paris on how to prioritize the different steps to implement CDISC Standards, from CDASH CRF designs to succeeding in an FDA Submission in the SDTM format. Ale also conducted Official CDISC Training in the Silicon Valley to share its expertise and promote CDISC standards in the industry.

The company’s commitment to global standards continues today. ClinCapture, its cloud-based EDC system, includes a CDASH-compliant eCRF Library.

Resources

Start creating your study at clincapture.com. For more information, please visit clincapture.com, contact us at [email protected] or +1 800 987 6007 ext. 2