Services

Process Optimization

Process optimization is one of the most sought after services from HERAX. As a clinical organization develops over time, from small to big, is divided, merged or specialized, processes start to become more imprecise due to a lack of focus on the organization as a whole.

HERAX can analyze and advise on how to improve processes all over the Clinical Development, and how to support these with the use of IT.


Operational Improvement
Process Analysis & Design
Lean Optimization
Clinical Data Standards & CDISC Implementation
Operational Improvement

Clinical Operations handles a multitude of tasks every day. Trial managers and monitors have an ever-increasing workload as trials become larger and more complicated. It is often necessary to look at the SOPs and align these across therapeutic and geographical areas, enabling easier processes, standard reporting and follow-ups. The introduction of clinical portals can also make life easier for operations both internally and externally when exchanging information with Investigators.

HERAX has helped many clients in these areas and can provide insight into how Clinical Operations can be improved.

Process Analysis & Design

Analysis of existing processes and design of new ones are the basis for many projects. HERAX provides several different ways to baseline, analyze and optimize processes often using the IDEF0 approach as this methodology is easy to understand and implement. All HERAX consultants are trained in the IDEF0 methodology, which is completely integrated in our unique Pharma Business Process Architecture®. The benefit of using HERAX for process optimization is our experience with Clinical Development processes, enabling us to provide insight and samples to inspire project members to create processes that are even more efficient.

Lean Optimization

Using Lean, forces the organization to look at customer value. In Clinical Development customer value can be seen as the value other departments derive out of what is being produced. With its emphasis on value creation and waste reduction in all processes, both in terms of calendar time, effort and material, Lean is a great tool to improve the organization.

HERAX can provide the tools, facilitation and clinical knowledge that makes a difference in a Lean project.

Clinical Data Standards & CDISC Implementation

Using data standards in Clinical Development brings a multitude of benefits across the entire clinical data chain, all the way from protocol development to report creations. The purpose of standardization is also to use industry standards to facilitate cooperation with External Service Providers (ESPs), CROs and development partners when exchanging data.

HERAX can help with the development and the implementation of clinical standards in all parts of the organization. As a gold member of CDISC, we support the development of vendor neutral and platform independent standards to improve data quality and accelerate development. HERAX can assist in all Clinical Development areas defining standards, governance and the most optimal implementation.