eClinical program design and implementation
HERAX has designed, planned and implemented eClinical programs in several midsize and large pharmaceutical companies. Instead of running projects individually in different departments, the eClinical program coordinates the initiatives in multiple projects. The benefits to our clients have been an improved program overview and coordinated project benefits to support a decrease in development time.
Business Case development for IT implementations in Clinical Development
HERAX has developed business cases for EDC, CTMS, EDMS, CDMS, RIMS, IVRS, Supply, IT integration, SOA, and several eClinical programs. The benefits for our clients are clearly described project benefits, resource needs and plans.
Metrics development for Clinical Development and Clinical Operations
HERAX can assist in creating a full overview of status on all projects in Clinical Development or Clinical Operations with metrics for all important processes combined in a dashboard. This provides our clients with a clear operational and strategic overview.
Process optimization in Clinical Development
HERAX has provided process optimization services for Science, Data Management, Medical Affairs, Biostatistics, Safety, Clinical Operations, Clinical Supply, Procurement, IT support, IT development, Project management and other areas. With the HERAX Pharmaceutical Process Model™ we provide extensive support in process optimization and can provide multiple references within all areas.
Change management in projects
HERAX Change Management consultants have helped numerous projects with planning and implementing change management activities. By using Prosci®’s methodology, HERAX ensures a comprehensive approach covering all areas of change. The benefits are improved adaptation of process changes in the organization.
SOP design and writing
HERAX has created whole quality system frameworks with all SOPs defined and linked to improve Clinical Development and IT processes.
IVRS usage optimization (Supply improvement)
HERAX has assisted in improvement of the use of IVRS, from selecting the vendor to the configuration. Focus was on lowering the cost of using IVRS and shortening the time for defining and testing the solution for each trial, combined with optimizing packaging sizes.
Portfolio and trial planning optimization and supporting system implementations
HERAX has assisted clients in analyzing, specifying, selecting and implementing a trial planning system. The benefits were better portfolio overview and improved resource planning and utilization.
IT Governance and IT Integration projects
HERAX has assisted clients with setting up IT Governance processes to improve the use of IT spend to focus on business benefits. In Clinical Development, IT systems are often setup as islands of information – HERAX helped the client with an integration strategy and selecting the platform.
CTMS solution implementation
The client was running clinical operations with the assistance of small databases and spreadsheets. HERAX helped analyze all processes, define the business case, select the vendor, configure and validate the selected solution, write SOPs and implement the system in the organization.
Clinical operations process redesign
The client has evolved over time and has expanded through acquisitions, and the SOPs and processes in different geographical areas of the company were not aligned. HERAX assisted with creating common process- and reporting structures, creating a global organization with the ability to cooperate better across departments.
Request for Information (RfI) and Request for Proposal (RfP) services
HERAX has created RfI packages for almost all systems used within Clinical Development. The benefits to the clients are reduced time usage, a complete market overview and an objective evaluation of responses. The benefits to our clients are: clear and objective selection criteria, effective solution scoring and a neutral selection process with emphasis on fulfillment of requirements.
Vendor negotiation planning and execution
HERAX has lately provided negotiation planning and execution assistance in the selection of major EDC, CDW, RIMS and CTMS solution. The benefits to our clients are lower prices and more services included in the negotiated contracts.
EDC project implementation
The client was using paper CRFs for all trials. HERAX provided advisory and project services assisting with business case, RfI, RfP, vendor selection, negotiation and implementation. The client benefited from HERAX’s implementation knowledge from previous EDC engagements, ensuring a project on track and budget, with a successful implementation.
Standardization (CDISC) implementation in Data Management and Biostatistics
HERAX assisted with creating the business case, project charter and implementation plan. The client has now successfully implemented the standard governance process and is standardizing on both Data management and Biostatistics based on CDISC.