E6 Clinical Trials at every step
E6 Clinical Trials is a leading site management organization that provides comprehensive and customized services for clinical research in pharmaceuticals, medical devices, CROs, biotechnology and health-related products. We believe in the true value in our people, relying in their global communication and technological capabilities for the clinical process while we maintain complete control.
What We Do
Successful clinical trial management involves a harmonious blend of expertise, technology and processes. We bring these elements together to deliver world-class clinical trial sites in multiple therapeutic areas for studies in any phases.
- •Project start up processes
- •Feasibility and site capacity assessments
- •Qualification site selection process
- •Budget and contract negotiations
- •Protocol review study synopsis
- •Subject recruitment strategies
- •Weekly status and enrollment reports
- •Project Managers with significant expertise
- •Study and sub-investigators, coordinators, auditors, and project assistants
- •Healthcare professionals assisting project coordinators
- •Staff education on GCP requirements
- •CRO engagement and oversight
- •Sponsors representative training services
- •Regulatory approvals submissions
- •IRB/IEC submissions
- •Ethical committee communications
- •Pre-site qualification assessments
- •Study documentation preparation
- •Clinical site networks
- •Patient recruitment by study requirements
- •IT infrastructure
- •Scheduling and management services
- •Workspace and interview room access
- •Medical examination facilities
- •IT infrastructure management
- •Laboratory management
- •Facilities management
- •Equipment management
- •Custom patient recruitment and logistics
- •Patient databases management
- •Recruitment progress monitoring
- •Integrated patient data and analytics
- •Patient follow-up and retention strategies
- •Local protocol adaptation for maximum patient compliance
- •Secure mobile data entry
- •Clinical data quality checks and verification
- •Automated data submission
- •Surveys of collected data
- •Global Clinical trial regulatory oversight
- •Core clinical trial protocol consulting
- •Compliance filings and submissions
- •Address any compliance-related issues and queries
- •Document management from source documents through to TMF
- •Creation of standardized SOPs
- •Expert review of regulatory documents
- •Proper events reporting of AEs and SAEs
- •Ensure proper handling of documentation
- •Identify and manage stakeholders
- •Ensure stakeholder alignment
- •Create engaging reports, presentations, summaries
- •Conduct stakeholder engagement meetings
- •Financial study budget development
- •Budget-to-actual budget management
- •Tracking invoices for payments and approvals
- •Reconciliation of payment reports
- •Project Management Software
- •Database creation for contact details
- •In-house Communication
- •Protocol adherence on regulatory compliance
- •Harmonize and Synchronize documentation with trial actions
Our Experience
Trial Setup
Experienced in phase I-IV trials and BA/BE (early phase trial).
Submission
15+ Trials (Including USFDA & DCGI)
Investigator Initiated Trials
2+ Trials
How we do it
We leverage our expertise, experience, and excellence to ensure the success of your clinical trials. We have:
A team of highly qualified, trained and experienced through all clinical trial phases and in critical therapeutic areas. Our research team focuses on excellence at the sponsor level.
Our team's main strength is creating professional presence at the research site, working with current and FDA, Local regulations, PCP Sites experiences, CRO relationships to ensure an effective completion of protocol tasks.
A system of consistent and rigorous clinical research sites across the organization, operating to high-level standards, with an experience and state of the art facilities and equipment.
A track record of accomplishing tasks within complex timelines, sites, and technologies, that enable us to streamline the clinical trial across a wide range of the trial, site types, and approach the project in creative and agile ways.
Why Us
We're committed to providing you with first-rate, comprehensive site-in-site management services for your clinical research needs. By choosing us, you benefit from:
Strategic Collaboration
We establish strong relationships with both sponsors and pharma companies for enhanced outcomes and a world-class service delivery approach.
Hospital Affiliations
Partnerships with local governance and private hospitals enable access to diverse patient populations and research resources.
Patient Retention
Our competitive, fair payment schedules ensure high enrollment and retention rates, enhancing study completion and reliability.
Clinical Expertise
Extensive experience in various populations, including pharmacokinetics/dynamics, FIH trials, bioequivalence, clinical research consultants (CRCs), and robust research teams.
Process Standardization
SOPs implementation prevents site-specific standard operating procedures, enhancing consistency across all locations and enabling comprehensive assessment.
Issue Resolution
Full-Service Support + Help-desk team and colleagues.
Therapeutic Areas
Central Nervous System
Psychiatry
Dermatology
Gastroenterology
Orthopedics
Endocrinology
Neurology
Rheumatology
Urology
Ophthalmology
Oncology
Pediatrics
