MakroCare is a specialist in the review and reconciliation of Safety and Adverse Event data obtained during the different phases of Clinical Trials and the Post-Marketing phase. At a time when regulations in the area of safety reporting are evolving and becoming more stringent, MakroCare is poised to help pharmaceutical or biotech companies scrupulously meet and sometimes exceed the exacting demands of a critical component of safety reporting.

MakroCare's unique capability to function as a "satellite" or as an "extension" division of each sponsor's business has created a unique platform for the process-driven component of managing safety for sponsors. Critical safety functions can remain in-house under the tight control of the sponsor, while process-driven aspects can be outsourced to expedite processing, reconciliation, reporting and query resolution. We offer drug safety services during the clinical trial phases as well as in the post-marketing phase.

Increasingly, regulators and licensing partners require electronic reporting of individual case safety reports. Our database complies fully with the validation, MedDRA coding and security standards defined by ICH E2B and the FDA's 21 CFR Part 11. Additionally, our electronic reporting services allow expedited reporting to authorities as well as transmission of additional data. At MakroCare, your safety data are hosted in a protected IT environment.

MakroCare's experts have the necessary expertise and regulatory know-how to help sponsors effectively develop safety management programs and ensure regulatory compliance. Please contact us to find out more about how MakroCare's safety processes can be easily integrated with that of sponsors for effective results.