• News
  • Contact
  • Login
Everyone Deserves to Be Well

Pharmacovigilance and Medical Monitoring

Changing regulatory environments and an increasingly litigious climate have converged. Biopharma innovators must practice exceptional risk management now more than ever.

ARG Drug Safety is paving a path of excellence with a strong commitment to protect public health and patient safety.

Our Mission is to provide our clients with a division of Safety Professionals that can comply with global regulations, operate under GVPs, and can assist with and exceed our clients expectations for safety services. Our goal is to support the safety of our subject's through superior pharmacovigilance expertise by employing senior level professionals with the background and experience to help lead our clients through the successful delivery of a product. We obtain and maintain accurate, up-to-date, and complete safety information for our clients by utilizing known and validated systems, innovative processes, and ensuring full, unbiased, scientific safety information is available to all stakeholders.

We aim to integrate drug safety into all functional service groups to improve communication and mitigate/minimize any known or unforeseen safety risks and to provide transparency for our services and outcomes.

We know Good Vigilance Practice. We combine the efforts of physicians and Drug Safety personnel with proprietary systems and operational infrastructure to ensure the excellence, transparency and reliability in execution for which ARG is known. Our employees are trained on current regulations and are supported with continuing education within the Drug Safety/Pharmacovigilance field to ensure that we are providing our clients with superior knowledge and consultation services. We provide End-to-End ICSR Processing and case management:

PV Risk: REMS and RMPs (timetable assessments, medication guides, ETASUs, and more) Pre- and post-marketing surveillance Aggregate reports: PBRERs, PAERs, DSUR, and PSURs DSMB support & management SAE management Endpoint CRFs: Clinical event validation and adjudication MedDRA term coding Safety/PV consultancy Case receipt, triage, and processing Case evaluation by medical professionals Coding of drugs in WHO-Drug Quality Review Expedited submission to Investigators, Health Authorities, subsidiaries, and other governing entities as applicable.

As regulatory bodies (FDA/EMA/PRAC) increasingly establish methodologies and requirements for aggregate data, it is becoming critical to increase efficiency and accuracy in assessing therapies' benefit-risk characteristics.

ARG provides best-of-breed technology systems and the in-house knowledge to apply these solutions to your unique therapies. Our comprehensive understanding of the latest global regulatory environment will ensure the safety of your biologics, compounds, or devices are accurately reported and that the reports (SAE/ADR/MDR) are managed in a way that withstands regulatory scrutiny.

Implementing scalable, robust clinical data systems at the beginning of a program can save money in the long run. Here are some emerging issues that make GVP (Good Vigilance Practice) for multi-country studies more complex and expensive:

Pharmacovigilance System Master File (PSMF) is now a requirement of the EMA. PBRERs, PAERs, and PSURs - FDA/EMA guidance promulgates PBRERs in place of other reporting requirements Automated databases hold promise for improved use of aggregated population data Social media and adverse event reporting Data issues: over- and under-reporting, missing denominator (doses of drug), wrong/duplicate/missing data