Clinical Operations Experts

Tailored services for clinical trials and Clinical Operations

Site management and monitoring.

Clinical Operations Management

Support for Sponsor Oversight

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Your Trusted Clinical Operations Partner

At PH Clinical Consultants, we specialize in providing expert contractor services in clinical operations for CROs, pharmaceutical companies, and biotechnologies, ensuring successful project management and strategic support.

Two people are working in a lab environment, both wearing lab coats. One person is seated and pointing at a computer screen, while the other is standing, looking at the screens. Multiple computer monitors display complex data, possibly related to scientific or medical research.

37+

11

Therapeutic Area

Clinical Studies

Since 2006, we have participated to 37 Clinical Trial in 11 Therapeutical areas from Dermatology to Cardiology, Infection disease to Oncology. Over 30% of these trial are early stage development (Phase 1-2), 49% in Phase 3 and 19% are device trials.

Clinical Operations Consulting

Expert support for companies transitioning from the bench to the clinic. Let our expert guide you to a faster and more cost efficient way of doing things. From the planing of clinical program to the management of a Clinical trial. We can support you in your clinical development.

woman in blue scrub suit standing beside woman in white robe

A scientist in a white lab coat and safety goggles is working in a laboratory. The scientist is interacting with a computer and a large, complex piece of lab equipment that is likely used for automated processes. There are several objects present including a cardboard box labeled 'Glass Disposal', various laboratory instruments, and a computer monitor displaying data. The lab is well-lit and organized with cabinets and shelves containing various lab supplies.

Risk Mitigation

Identification of key success indicator and tracking. Proactive and creative resolution of challenges and Change management. Regulatory compliance and Quality Assurance

Comprehensive Oversight

Coordination of cross functional teams. Vendor selection and supervision. Timelines and budget management

Clinical Operations: Study setup, execution, and close-out. Vendor selection and stakeholder coordination. Regulatory compliance and best practices. Mentoring in clinical Operations and support for project Oversight

Program and study Planning: Feasibility assessments and protocol design. Resource and budget planning. Regulatory and ethical approvals

Seamless Team Intergration

Delivering expert clinical operations consulting for your project's sucess.

Site management and Monitoring

Site Management: Site selection and initiation, Investigator and staff training. Day to day management of sites including enrolment support

Monitoring: Creation of monitoring plan and study specific tools. Remote and on-site monitoring. Data integrity and compliance tracking

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Project support Quality Management and partner services

Project support: Patient recruitment and retention strategies. Study document development. Day to day project support (Minutes, eTMF development and management, etc. Investigator site support. Regulatory document adherence monitoring. IP and non-IP supply management

Quality Management: SOP development and implementation. GCP compliance and regulatory adherence. Training and mentoring Auditing Services: Internal and external audits. Risk-based audit strategies. On site for cause or planned audits

Partner Services: Electronic applications: Electronic Case Report Form (eCRF), Electronic Trial Master File (eTMF) and Electronic Investigator Site File (eISF) Data management: eCRF development and build. Edit check programming, Data cleaning and querying

Bio Statistics: Statistical plan and sample size validation. Programming, Statistical Analysis

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