Services

IT Implementation

Today, all areas of Clinical Development are dependent on technology. Efficient use of technology is important to most processes from a strategic and an operational point of view. Any organization has a limited budget to use on IT, and it is therefore important to use the budget in the most effective way. HERAX can assist in ensuring that the IT strategy is aligned with the business needs, and that IT budgets are spent to provide the most benefit for the company.


IT Assessment & Planning
IT Governance
Vendor Evaluations
Use Case Development
User Requirement Specifications
Negotiation Assistance
RfI/RfP Development
IT Design & Configuration
IT Assessment & Planning

HERAX can assist with system assessments, to establish if the expected needs are covered and are competitive from a budget perspective. HERAX also assists with GxP and 21 CFR part 11 evaluations as well as the planning of bringing systems into compliance.

IT Governance

An effective IT strategy that aligns IT initiatives with business needs and outlines the focus of the organization’s resources as well as the basis for decisions on what can be outsourced, is all together grounded in good IT governance. HERAX can assist with implementing a Clinical Development IT Committee by creating the necessary processes and helping to start it.

Vendor Evaluations

Evaluation of vendors is often done with a subjective approach both in terms of commercial fit, IT and Quality Compliance, capabilities and project and implementation approach. As a part of HERAX Pharma Business Process Architecture® we have developed an effective and objective method to assess a vendor in all these areas, saving our clients many problems in projects by being able to address these issues up front.

The benefit of using our approach is a fast and objective evaluation that covers all aspects of the project in which the vendor is expected to be involved.

Use Case Development

When specifying a new IT system, Use Cases are very effective to ensure that the selected system can be used for the intended purpose in the intended way. By developing Use Cases in parallel with the User Requirement Specification (URS), the sponsor gets the material needed for asking the vendors to do a real demo based on Use Cases. For the later validation, it is easy to change the Use Cases into PQ test cases, thereby eliminating much PQ writing work.

HERAX provides an easy approach for writing Use Cases based on our methodology and many years of experience.

User Requirement Specifications

All systems used in any commercial setting should have a User Requirement Specification (URS). In validated environments this is a requirement and follows GAMP5 which is the de-facto standard for IT systems validation in the pharmaceutical business.

Based on numerous projects, HERAX has a fast and effective process for defining requirement specifications. This enables HERAX to create a good and usable URS mapped to Use Cases for both compliance and validation purposes. In addition to the URS, HERAX can develop both functional and system specifications.

Negotiation Assistance

HERAX provides assistance in setting up and participating in commercial teams when negotiating with IT and software vendors. This service is very valuable, as even small price reductions and added services with no additional fees can save substantial sums and internal resources.

The benefit of using HERAX is our commercial negotiation approach combined with a large knowledge of prices and discounts in the market. The consultants we provide for this service are certified in negotiation techniques from Stanford University and provide very valuable advice.

RfI/RfP Development

Request for Information and Request for Proposals are used for most purchasing decisions when selecting IT solutions. HERAX are experts in both creating the necessary packages and in running the demonstration and scoring process to ensure an objective selection result. We have created RfI and RfP packages for many EDC (Electronic Data Capture), CTMS (Clinical Trial Management System), EDMS (Electronic Document Management System), CDMS (Clinical Data Management System), Clinical Portal, Clinical Data Warehouse, and RIMS (Regulatory Information Management System) solutions.

The benefits of using HERAX for RfI and RfP work is our efficient process and the optimal use of the often substantial amount of time required by internal specialists for scoring and evaluation.

IT Design and Configuration

Implementing IT systems in Clinical Development always includes a phase for deciding on design and configuration options. When doing this, all decisions have to reflect the agreed processes and data requirements.

HERAX provides an efficient method to assist with Design Specifications and Configuration documents to facilitate this process. In addition, HERAX can provide input based on best practice from previous implementation projects to ensure all options are considered. All documentation developed is in full GAMP5 compliance.