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Description

ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.

Description

HEKMA is a pioneering company utilizing artificial intelligence to enhance the efficiency of clinical trials by optimizing patient recruitment, assessing trial feasibility, and fostering patient engagement. Their comprehensive platform caters to a diverse audience, including contract research organizations (CROs), pharmaceutical sponsors, healthcare facilities, and patients, by integrating electronic health records (EHRs) with AI-driven trial matching, clinical trial management solutions, and tools for engaging patients. The core mission of HEKMA is to minimize delays in enrollment, broaden access to clinical trials—especially for underrepresented communities—and streamline the clinical research process to ensure it is more efficient, transparent, and centered around patient needs. With a blend of healthcare knowledge, artificial intelligence capabilities, and clinical operations expertise, HEKMA adheres to crucial industry regulations such as HIPAA, 21 CFR Part 11, GDPR, and HL7/FHIR, ensuring the highest standards of compliance. By harnessing innovative technology, HEKMA aims to transform the landscape of clinical trials, ultimately contributing to advancements in medical research and patient care.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial Yes 
Free Version Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux Yes 
Chromebook Yes 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Innovate Research

Founded

2014

Country

India

Website

innovate-research.com/clinsoft/

Vendor Details

Company Name

HEKMA

Founded

2018

Country

United States

Website

www.hekma.ai/

Product Features

Clinical Trial Management

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

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

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