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 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
the IT strategy is aligned with the business needs, and that IT budgets provides the most benefits
and IT areas, GxP, Validation,
CDISC, Software Development and SOP/Quality system writing/development
"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
Market Trends and Solution Selection for Clinical Applications - March 18th, 2020, CET 15.00
Organizational Change Management.
Regulatory Requirements for Medical Devices.
Is your organization keeping up with the increasing regulatory requirements for medical devices?
Sine Annfeldt promoted to Team Manager.
HERAX is happy to announce the promotion of Sine Annfeldt to Team Manager.
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 requirementsRead more
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.
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...