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What is Protocol Manager (CTMS)?

The Protocol Manager plays a crucial role in clinical operations by managing global trials across different phases of drug, device, biologic, and vaccine development. It establishes essential Standard Operating Procedures (SOPs) to ensure adherence to FDA's 21 CFR part 11 regulations. Utilizing Web Services technology, the platform enables seamless and automatic integration with a variety of popular EDC and IVRS solutions. For systems that do not support Web Services, an export/import feature is provided to facilitate integration. This all-encompassing tool includes a robust tracking system and database, enabling effective management of diverse trial information and metrics, which significantly boosts operational efficiency. Furthermore, it allows organizations to uphold stringent oversight throughout the trial process, safeguarding data integrity and ensuring compliance at each phase. As a result, the Protocol Manager not only streamlines operations but also supports the successful execution of clinical trials by promoting transparency and accountability.

What is Clin'form?

Clin'form is a robust and flexible electronic Clinical Outcome Assessment (eCOA) platform designed to enhance the efficiency of clinical trials for both participants and research facilities, while also improving data accuracy and expediting processes for research teams. Its adaptability allows it to be utilized across a wide array of protocols and demographics, making it ideal for any questionnaire type, including Patient-Reported Outcomes (PRO), Observer-Reported Outcomes (ObsRO), Clinician-Reported Outcomes (ClinRO), and diaries, catering to a diverse demographic from children to seniors. The platform is engineered to accommodate varying population sizes, effectively managing studies that involve small cohorts as well as those with more than 10,000 participants across multiple global locations. Clin'form seamlessly integrates with other clinical systems to create an efficient workflow, supporting a range of data collection methods—including dedicated tablets, smartphones, patients' personal devices, web access via any browser, and in-person interviews. A standout feature is the integrated tele-visit option, which provides flexibility in response to unforeseen changes, along with patient engagement tools that are designed to foster high compliance rates. Furthermore, the intuitive interface of Clin'form ensures that both researchers and participants can navigate the platform with ease, thereby enhancing the overall clinical trial experience and effectiveness. Overall, Clin'form not only streamlines the data collection process but also places a strong emphasis on user experience, making it a valuable asset in clinical research.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Kayentis

Date Founded

2003

Company Location

France

Company Website

kayentis.com/clinform-ecoa-solution/

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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