Services

Process Optimization

SOP Development

Process Framework Development

Process Analysis, Optimization and Digitalization

Process Analysis, Optimization and Digitalization

Want to hear more? Please contact:

Herdis Stavnsgaard

Project Director

+ 45 3049 9634

hst@herax.com

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

Business Consulting

Business Case Development

Project and program planning, execution and assistance

Digital Strategy

Digital Strategy

Want to hear more? Please contact:

John Aggerholm

Project Director

+ 45 2231 5041

jag@herax.com

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

Compliance

Vendor Audits

GxP/GDPR Compliance

IT Validation

IT Validation

Want to hear more? Please contact:

Sophie Hytteballe 

Senior Project Manager

+ 45 3049 6800

shy@herax.com

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

IT Implementation

RfI/RfP Services

Requirements Development

Vendor and Application Selection

Implementation of Solutions

Change Management

Vendor and Application Selection

Want to hear more? Please contact:

Jacob Jensen

Senior Project Manager

+ 45 3049 2300

jje@herax.com

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

Project and Operations Assistance

Clinical & Device Application Specialists

Operations Assistance

IT Systems Implementation and Maintenance Best Practices

Project Managers and Business Analysts

Project Managers and Business Analysts

Want to hear more? Please contact:

Sine Anfelt

Project Manager

+ 45 6130 0482

san@herax.com

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

Training Academy

Pharma Introduction

Pharma IT Project Execution

Want to hear more? Please contact:

Sofie Jespersen

eLearning Specialist

+ 45 3049 1161

sni@herax.com

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

Contact us

Denmark & Europe

Tel. + 45 3049 0080

Email: contact@herax.com

Switzerland

Tel. + 41 445 853 049

Email: contact@herax.com

USA

+ 1 (703) 436 9921

Email: contact@herax.com

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