HERAX

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

At HERAX we have extensive knowledge of the life science industry and an experienced team

All our 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

At HERAX, we are specialists in virtualizing clinical trials and can assist and advise on what is needed to go virtual with a trial

HERAX offers leading experience with all technologies used in Life Science

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

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

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

Compliance

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

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

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

Take a closer look at the new Medical Device Regulation

How to make your data FAIR through Data Standardization

New EU Clinical Trial regulation is going live

Get an up to date process landscape

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

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.

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...

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...

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...

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

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

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