Services

Project Assistance

HERAX’s clients are often looking for project assistance for small as well as bigger projects, where it is beneficial to the project to have a consultant with competencies both from Clinical Development as well as our specialist areas. For specific short and medium term assignments, HERAX can provide this assistance.

HERAX provides assistance to areas within Clinical Development and IT such as SOP writing, quality assurance, and all forms of IT implementations. Our consultants come with the full toolkit based on our Pharma Business Process ArchitectureTMenabling them to produce all deliverables with a consistent high quality level. When providing project assistance, HERAX consultants can follow either HERAX or the client SOPs.

Below some of the specific areas are mentioned, where our clients most often ask for a consultant to help them.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. to identify which profile you need, and state how HERAX can help you.


Project Management
Business Analyst
Validation & Test Management
Vendor Management
Quality Management
Project Management

HERAX project managers are highly experienced with certifications in either PIM or the PRINCE2 project management methodology. In addition, they all have extensive professional experience with Clinical Development, and several IT solution implementations. A project manager from HERAX can really make a difference when implementing new processes or IT solutions in Clinical Development.

Business Analyst

Consultants with Clinical Development experience combined with process- and IT project skills are needed in most projects within Clinical Development. For analysis, specification, configuration, change management and other project work, HERAX senior consultants are able to provide assistance and make the project life easier and less time consuming for the client's line of business resources.

Validation & Test Management

In pharma system validation, test management is important to ensure an effective validation. HERAX Test Managers are experienced in creating validation plans, requirements, test plans and tests. All deliveries needed for a GAMP5 compliant validation can be provided.

Vendor Management

For larger projects, it is often beneficial to have a neutral consultant dealing with vendors, both to release staff to do their daily work but also to benefit from our specialist request for proposal (RfP) evaluation and negotiation skills. HERAX can also make a difference in most negotiations as we know the price and discount levels from most vendors.

Quality Management

HERAX can provide specialist consultants with major experience in the areas of SOP evaluations, quality system assistance and 21 Part 11 assessments. HERAX further provides assistance with a suddenly increased workload in QA or IT QA.