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What is OpenText Clinical Trial Quality Management?

In the past few years, the Life Sciences industry has faced fines and settlements totaling almost $15 billion due to compliance issues, highlighting the critical need for companies to adhere to best practices in pharmaceuticals, medical devices, and biotechnology. Furthermore, the management of clinical trials significantly impacts the duration, scope, and financial investments necessary for the advancement of drugs and medical devices. By leveraging OpenText™ Clinical Trial Quality Management System (ctQMS), organizations can ensure compliance, reduce record-keeping costs, and promote collaboration to implement best practices throughout the clinical trial process. This strategic methodology not only boosts operational efficiency but also plays a vital role in the successful development of products. Ultimately, embracing such advanced systems can lead to more innovative solutions in the healthcare landscape.

What is HEKMA?

HEKMA stands at the forefront of innovation, leveraging artificial intelligence to improve the effectiveness of clinical trials through enhanced patient recruitment, evaluation of trial feasibility, and improved patient engagement. Their all-encompassing platform serves a wide range of stakeholders, including contract research organizations (CROs), pharmaceutical companies, healthcare providers, and patients, by combining electronic health records (EHRs) with AI-enhanced trial matching, clinical trial management systems, and patient engagement tools. HEKMA's primary objective is to reduce enrollment delays, increase access to clinical trials—particularly for marginalized groups—and streamline the clinical research workflow to create a process that is more efficient, transparent, and focused on patient requirements. With a unique combination of healthcare expertise, artificial intelligence technology, and clinical operations knowledge, HEKMA ensures compliance with essential industry standards, such as HIPAA, 21 CFR Part 11, GDPR, and HL7/FHIR, maintaining the highest levels of regulatory adherence. By embracing cutting-edge technology, HEKMA aspires to revolutionize the clinical trial landscape, ultimately driving progress in medical research and enhancing patient outcomes. Their commitment to innovation not only addresses current challenges in clinical research but also positions them as leaders in shaping the future of healthcare.

Media

No images available

Media

No images available

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

OpenText

Date Founded

1991

Company Location

Canada

Company Website

www.opentext.com/info/clinical-trial-management

Company Facts

Organization Name

HEKMA

Date Founded

2018

Company Location

United States

Company Website

www.hekma.ai/

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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