Project Assistance

Our Service

Overview

Clients are often looking for assistance with projects, with competencies ranging from project Management, Business Analyst to Solutions Specialist etc. – All with competence from R&D and our other specialist areas.

HERAX can provide this assistance in all project phases (Analysis, Planning and Execution) in the areas:

Project & Program Management – Highly experienced Project Managers (SCRUM, PIM, Prince II certified)
Business Analysis – Clinical, application and IT experience
Clinical & Device Applications Specialist – Clinical Application Specialists cover systems like CTMS, EDC, MDR, CDW, CDR, Safety, Coding, Reporting applications, RIMS, eCTD etc.
Operations Assistance – System maintenance, support, and upgrades in the most efficient way. HERAX operates and handles upgrades for many clinical systems for our clients
IT System, Maintenance and Outsourcing best practice – Single expert help with implementations. HERAX can assist with the specifically needed skills for tasks such as validation or outsourcing, and process analysis
Validation & Compliance – Supporting implementations and compliance work in both process and IT projects
Migration planning and execution – Experience is key with migrations, and HERAX can help with both planning, data cleaning and execution of migrations

Project assistance is offered both onsite and remote. Remote assistance allows HERAX to support in smaller or more specialized areas, where key competences are needed in a shorter time period.

Project Management and Business Analysis

We have highly experienced Project Managers (SAF®, SCRUM, PIM, Prince II certified) and Business Analysts with clinical and IT experience.

Clinical & Device Solution Specialist

Our Clinical Solution Specialists cover systems like CTMS, EDC, MDR, CDW, CDR, Safety, Coding, Reporting applications, RIMS, eCTD etc.

Why choose us

Expertise

With our deep knowledge of life science, we understand our clients' needs and provide genuine value.

Methodology

We use a proven agile methodology for life science that ensures high-quality work and efficient execution tailored to our clients' goals.

Working with us

We support all project phases with the same team and event-driven focus, which moves the project forward.

Explore more services

Validation and Compliance

We ensure compliance and validation through risk-based approaches, delivering end-to-end support from documentation to vendor audits and SOP development.

Vendor and Application Selection

We help objectively select and evaluate vendors, from developing requirements to final negotiations, ensuring the best fit for your business needs.

Drug Safety

We develop AI/ML strategies for Pharmacovigilance, ensuring secure, compliant, and optimized processes from planning to implementation.

Operations Management

We provide ongoing solution operation and optimization, ensuring performance, compliance, and streamlined processes throughout the entire system lifecycle.