MACRO is a powerful, industry-standard electronic data capture solution that has been proven in commercial and not-for-profit clinical research for over 20 years.
MACRO is compliant with all applicable laws and regulations on the conduct of clinical trials. For over 20 years MACRO has been used to conduct interventional clinical trials (CTIMPs) for both FDA and EMA submission.
During this time, MACRO has been audited numerous times to confirm compliance with ICH E6 Good Clinical Practice guidelines, FDA 21 CFR Part 11 and the EU Clinical Trials Regulation, including direct GCP inspection by the MHRA. With MACRO, you can be confident that your EDC compliance needs are met.
MACRO’s dynamic and easy-to-use tools for study definition, data capture and data management simplify study set-up, reduce time to first data entry and to database lock and help researchers succeed every time in increasingly complex clinical trials.
MACRO is used by pharmaceutical companies, academic medical centres, medical registries, CROs and medical device companies.
Elsevier offers a range of services to help users to 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. Elsevier also offers MACRO as part of a study-hosting service, providing a secure, validated environment in which clients can run MACRO clinical studies
MACRO is developed to meet the clinical research needs of pharmaceutical companies and major CROs. Elsevier now offers this industrial-strength EDC to academic medical centres, clinical trials units, therapeutic area research groups, medical registries and charitable organisations, at a price they can afford.
As EDC becomes the norm in clinical trials, users look for proven technology that is adaptable, user-friendly and meets their needs for efficiency, cost-effectiveness and regulatory compliance. MACRO is the professional solution.
MACRO has been used for hundreds of studies globally. One global pharmaceutical company has used MACRO to support studies involving almost 30,000 patients and 6,000 users, whilst another collected over 12 million data responses across 278 sites over a 3-year period.