Services

Business Consulting

HERAX's focus on the pharmaceutical and diagnostic sector clearly shows in the business consulting projects we are engaged in. These include planning of eClinical programs, projects coordinating the impact on operational speed and other key trial metrics in Clinical Development, analyses of processes. Furthermore, this includes the creation of single project business cases and project plans for both clinical and IT departments. Finally, it includes all types of system implementations such as EDC, CTMS, RIMS, IDMP, EDMS, clinical portals, clinical data warehouses etc.

Our life science knowledge ensures that the projects are rooted in actual business benefits, which are realistic to implement.


eClinical planning & execution
Business Case Development
Metrics Identification
Portfolio Planning & Tracking
Outsourcing Strategy & Implementation
eClinical Program Advisor
eClinical Planning & Execution

HERAX provides eClinical advisory services and execution assistance. An overall plan and a series of business cases are essential when planning an eClinical program with multiple projects. This ensures that the benefits for each project are planned to support each other and that the common operational and strategic goals of Clinical Development are supported. HERAX assists with the necessary analysis, planning and execution phase.

The benefits to the client are a focused eClinical project, started with business objectives in mind and with clear activities and milestones all the way to completion.

Business Case Development

Before starting any form of project, it is often preferable to write a business case, outlining the changes in process, organization and maybe IT that will lead to the expected benefits. Combined with an implementation plan, this enables Clinical Development to decide how to approach the initiative, how many resources should be allocated and finally to secure a management decision to execute the project.

HERAX are experts in developing business cases based on our Pharma Business Process Architecture® working through a proven and efficient process together with our client, to create a comprehensive case, covering all areas of a project idea necessary for an approval to start.

Metrics Identification

Metrics are essential for all organizations to ensure that goals are met and that the organization improves on its targets. In Clinical Development, it is important to assess both micro metrics, such as protocol development time and enrolled subjects per site, and macro metrics, such as process outsourcing percentage, subject recruitment in emerging markets and internal performance compared to industry averages. HERAX can help define micro and macro metrics and how to measure these.

The benefits to the client are faster definitions of metrics, identified baseline numbers and a process for measuring and following up on defined metrics. Defining and measuring performance using metrics often starts initiatives for improvement.

Portfolio Planning & Tracking

Creation of an integrated clinical portfolio and a project management process supported by automated processes is key to delivering Clinical Development organization objectives. HERAX assists the client in building a better process for portfolio review, resource modeling and project planning.

Clinical Portfolio, Project and Resource Management systems are very important for an organization's ability to plan and align resources with clinical and corporate objectives. The benefit of using HERAX is that we can assist in analyzing the planning process, suggest improvements and help implement the changes. Currently, many companies implement large Project and Resource Management solutions, and here HERAX can assist in making the project operational and measurable from a clinical operational perspective.

Outsourcing Strategy & Implementation

In order to stay competitive, pharmaceutical companies have to look at outsourcing as a way of optimizing operations. In clinical operations, it is often outsourcing of trials to CROs or outsourcing of specific areas of a trial, like data management, handling of safety cases or monitoring. In IT, it often relates to outsourcing of support, operation or development of IT systems.

HERAX provides multiple consulting options in order to help both Clinical Development and IT organizations with outsourcing strategies, defining the associated benefits and savings, as well as how to implement these.

eClinical Program Advisor

In addition to developing eClinical programs, HERAX provides program advisors to eClinical, Clinical Development and IT projects. The experience we bring to the program in planning a realistic process and IT implementation outweighs the expense many times. Our experience ensures precise scope and approach, and ultimately prevents mistakes.