HERAX helps its clients digitalize their business and become more effective and assists with selecting and implementing the best IT systems and improving processes

High-Quality Business & IT Consulting for the Pharmaceutical, Medical Device and Biotech Industries

At HERAX we have extensive knowledge of the life science industry

All consultants have professional experience within Life Science and IT implementations

For pharma and biotech HERAX focuses on the Clinical Development, Clinical Operations, Regulatory, Quality, and Pharmacovigilance business in all services

HERAX offers leading experience with all technologies used in Life Science

Services

Business Consulting

Digital improvement programs, covering all from R&D, coordinating the impact on operational speed, subject enrollment and other key trial metrics, to creating single project business cases and project plans


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Compliance

HERAX offers a full range of compliance advisory services, revision and development of new SOPs and compliance evaluation in implementation projects




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Process Optimization

Process optimization is one of the most sought after services. As an organization develops over time, processes become more imprecise. We advise on how to improve processes and how to support these with clever IT


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Project Assistance

Clients are often looking for assistance for both small and bigger projects within the Clinical Development area. We provide project assistance for short and medium term assignments, within all of our specialist areas


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IT Implementations 

Efficient use of technology is important to processes from a strategic and operational point of view. We assist in ensuring that
the IT strategy is aligned with the business needs, and that IT budgets provides the most benefits


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Training Academy

HERAX provides industry training in Pharma Development and Project Execution for both the Clinical
and IT areas, GxP, Validation,
CDISC, Software Development and SOP/Quality system writing/development


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"Working with HERAX is always a pleasure, as they know everything about Clinical Development, and how that can be made better with the right processes and systems. Our vendor selection and implementations have improved significantly"


Head of Clinical Development

Agile Project Development for Pharma, Biotech and Medical Devices

Planning and developing solutions in a regulated environment has been traditionally inflexible.


HERAX incorporates SCRUM in our methodology, allowing for a flexible and fast implementation that unlocks business potential, while ensuring team productivity, delivering continuous results and allows for change requests within the iterative configuration phases improving the business satisfaction with the end product.


An agile approach combined with a risk based validation method ensures a cost effective test of only configured business and regulatory requirements

Latest News

Organizational Change Management

 

Are you having issues ensuring that your Organizational Change Management (OCM) efforts sufficiently inform end-users of organizational changes in order to maximize adaptation for your IT implementation or optimization ...


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HERAX Webinar                           


Market Trends and Solution Selection for Clinical Applications - May 20th, 2020, CET 15.00. Please join your colleagues in Clinical Development, both business and IT, to hear the latest about the market for Clinical ...

Regulatory Requirements for Medical Devices

 

Is your organization keeping up with the increasing regulatory requirements for medical devices? The medical device industry has recently been, and will most likely continue to be, subjected to strengthened ...

Sine Annfeldt promoted to Team Manager

 

HERAX is happy to announce the promotion of Sine Annfeldt to Team Manager. Sine has worked at HERAX for almost 5 years, with clients from the pharmaceutical industry both in Denmark, Switzerland and ...

Customer Success Stories

EDC Selection & Implementation            


The client wanted to move from 100% paper CRFs to 100% EDC for new trials, with the data integrated into their Clinical Data Management System for creation on raw SDTM analysis files. The goal was achieved in 10 months, from initial idea to go-live, and reduced the time from LPLV to database lock to 2 weeks.


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Clinical Portals strategy, selection and implementation 


The client needed one place for all study teams to work and share files and operational information for studies being run internally and outsourced to CROs. In order to support all study scenarios, a flexible portal with modules was needed. Analysis and strategy were done in 3 months, and the first trial... 


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SOP analysis & new process framework


The client’s business had rapidly expanded over the last ten years and was now facing the challenge of a fragmented and cumbersome SOP landscape with no overall structure. They needed to develop a new optimized and aligned framework that was scaled to match the pharmaceutical company they...


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Midsized pharma client implemented eTMF within 9 months


Client wanted to spin out it’s drug discovery operations into a new company within a strict timeline. This included transition of a number of studies and associated documents to a new integrated eTMF solution fully applying to DIA reference model 3.0, with no or limited time to fail



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CTMS strategy, selection and implementation


The company needed to align the processes in all 4 divisions, and create a consolidated view of all trial planning and execution activities. Implementing best practice for RBM in order to save time for monitoring, giving the capability to run more trials with the same staff. Migration of old legacy systems, new processes and training...


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Statistical Computing Environment, MDR and new processes


The client was struggling with
local installations of statistical programming tools making it difficult for the IT department to manage and support. The statistical programmers experienced slow connectivity to data which resulted in local copies of programs and datasets. Cumbersome manual processes for data access...


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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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