MACRO EDC in clinical research

Local installation or study hosting

Local MACRO installation

Elsevier offers a range of services to help users install and configure MACRO and to integrate MACRO into their working practices. Because of its ease-of-use, MACRO is an ideal introduction to new EDC technology.

We also offer extensive support in the following areas:

  • Software & Hardware Installation - server installation & configuration, database configuration, network client machines, web client machines.
  • Study Definition Consultancy - whilst study set-up is straightforward with MACRO, we also offer a study definition service, working from your clinical protocol and annotated CRF to define your study in MACRO.
  • Study Definition Audit - expert review and analysis of study definitions along with recommendations for optimising performance and making the best use of EDC's capabilities.
  • Systems Administration - user role management, security issues, secure socket layer encryption, digital signatures, IP addresses, network administration, system updates.
  • Systems Validation - validation procedures and documentation against GCP and other regulatory criteria, Standard Operating Procedures.
  • Consultancy - advice and guidance on issues related to software implementation in the clinical trials environment.
  • Server Specification or Server Performance Testing and Analysis.
  • Operational Qualification Testing.
  • Basic and Advanced MACRO and Arezzo training courses - conducted on-site at Client locations or at public training courses scheduled throughout the year in London and select locations in the UK.
  • Bespoke training courses on topics of particular need or interest to individual customers.

Study hosting (Software as a Service)

Elsevier also offers MACRO as part of a study hosting service, providing a secure, validated environment in which clients can run MACRO clinical studies in partnership with the hosting company Rackspace®.

Benefits of the 'Software as a Service' (SaaS) hosted option for MACRO include:

  • An easy validation process, driven by experienced InferMed professionals, providing required regulatory documentation and helping design best fit for validation of your internal processes.
  • An accelerated implementation schedule, with the system operational, validated and ready to use from day one.
  • Significant cost savings - eliminating the need for investment in expensive server hardware.
  • The removal of the hassle of IT administration, maintenance, patching and back-ups, the unit safe in the knowledge that the system is administered by application and hosting experts.
  • A robust, powerful and secure IT infrastructure, as used by top blue-chip companies.
  • Scalability assurance, the hosting solution guaranteed to meet a client`s future requirements and performance.

Click here to request our MACRO Description Document with a more detailed description of the MACRO technology.