Services

Digital Strategy

How do you digitalize all of Clinical R&D to become more scalable, agile and cloud based? HERAX can help develop a strategy for how to achieve effectively

Business Case Development

Optimizing the business takes time, effort and investments. With a good business case developed by HERAX you know the cost and exact benefits

Project and program planning, execution and assistance

Planning a digitalization program in detail with new processes, executing it with the right resources to ensure success, and ensuring benefits are realized

Process Analysis, Optimization and Digitalization

HERAX provides process analysis, As-Is, To-be, GAP analysis, digitalization of processes, and how to optimize them based on our best of class experience

SOP Development

SOPs are essential to compliance. HERAX offers a full range of services from compliance advisory services, revision and development of new SOPs to compliance evaluation in implementation projects

Process Framework Development

To be efficient and scalable a great process framework is needed, with simple to understand levels and SOPs. We can develop and optimize your current setup

Vendor and Application Selection

Evaluation of vendors is done with a objective approach, both in terms of commercial fit, IT and Quality Compliance and capabilities based on our methodology

Implementations of Solutions

Using an agile method, effective vendor management with focus on processes, OoB functionality, GAMP5 documentation, and on budget due to good requirements

Change Management

HERAX can create a comprehensive Change Management plan, ensuring the changes and new processes get implemented in the organization

RfI/RfP Services

Experts in both creating the necessary RfI/RfP packages and in running the demonstration and scoring process to ensure an objective selection result

Requirements Development

User stories and User Requirement Specifications, supporting new SOPs, Configuration Specifications, aligned to save time and effort when implementing and maintaining the system

IT Validation

HERAX provides all validation services based on a risk based approach in compliance with GAMP5, CFR part 11 and ISO40123

Vendor Audits

IT vendor audits, evaluation of QMS quality and adherence, SDLC evaluations and service provider audits (Both IT and CROs)

GxP/GDPR Compliance

Good Clinical Practice and adherence to GDPR, both with new systems and with new processes is a specialty of HERAX

Project Managers and Business Analysts

Highly experienced Project Managers (SCRUM, PIM, Prince II certified) and Business Analysts with clinical and IT experience

Clinical & Device Application Specialists

Our 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 Systems Implementation and Maintenance Best Practice

Single expert help with implementations. HERAX can assist with only the specifically needed skills, for tasks such as validation or outsourcing, and process analysis

Project Managers and Business Analysts

Fundamentals of the core of the pharmaceutical industry; how a product is discovered, developed, tested and marketed for IT and clinical professionals

Clinical & Device Application Specialists

Effective project planning, requirements description, vendor selection, negotiation, configuration, implementation, validation and go-live, all in one course