Clinical Trial Services | Custom Research Solutions

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FROM DISCOVERY TO PATIENTS

Tailored Partnerships at Every Stage
of Your Clinical Trials

Project Management

Regional and international project management, portfolio strategy, full clinical development services.

Regulatory Affairs & Strategy

Regulatory consultations, submissions, and strategy throughout your product development cycle.

Clinical Science & Medical Affairs

Comprehensive medical services including monitoring, pharmacovigilance, writing, consultations, and more

Clinical Operations

Feasibility studies, monitoring, and end-to-end site management services.

Data Science

Streamlined clinical data management, biostatistics, and statistical programming services.

Quality and Audit

QMS establishment, risk-based quality management, and clinical trial audits.

Your Customized Clinical Research Strategy

Work with our team to overcome your R&D challenges

Regulatory Affairs

Early-stage product development, regulatory affairs consultation, application/ registration submission (IND/NDA/license lifecycle management).

Medical Strategy & Writing

Clinical trial protocol/ Investigator’s brochure/ Clinical research report writing
Liaisons with key opinion leaders.

Data Management & Biostatistics

Clinical data management
Statistical analysis
Programming

Clinical Trial Review & Training

Independent third-party supervision.
GCP training

Project Management & Clinical Operations

Project strategy development and management.
Feasibility and trial protocol design
Selection of clinical sites, trial start-up, and patient enrolment.
Clinical monitoring.

Pharmacovigilance

Handling of safety issues and regular report generation
Setup and management of databases

Real-World Data

Data analysis for project initiation (project design, selection of clinical sites, patient recruitment).
Construction and analysis of real-world research datasets (electronic health records, payer data, etc.)

Market Access & Commercialization

Health economics and outcomes research (HEOR).
Consultation on commercialization.

Clinical Trial Supply & Logistics

Streamlined management and distribution of ancillary supplies to support efficient and reliable clinical trials.

Clinical Site Management & Alliance Network

Negotiation and management of clinical sites/ investigators
Outsourcing models in clinical research

Real-World Evidence
(supporting scientific & commerical analysis and project development)

Observational studies.
Post-market studies.

Machine Learning-Enabled Services

Medical imaging.
Medical writing and communication.

Virtual Trials Supported by Wearable Devices

Leveraging our Expertise
to Make a Difference

Our team excels at strategically navigating the complexities of clinical trials. We stand as your trusted partner, dedicated to ensuring your scientific breakthroughs reach patients in need.

Make a Difference With HiRO