ARG's collaborative team approach to Clinical Trial Management — along with TrialVista®, our industry—leading CTMS solution — helps small and mid—sized biotech companies ensure that what must go right, does go right, and that what can go wrong, doesn't. The successful outcomes of this approach are exemplified by the following client interactions.

Pivotal Phase III Trial Undergoes Numerous Investigator Audits by the FDA

A pivotal Phase III clinical trial of C1 inhibitor for the prophylactic treatment of hereditary angioedema managed by ARG successfully underwent 3 investigative site audits by the FDA. The BLA submission for C1 inhibitor has been made to the FDA and approval is expected in 2008.

No major findings were noted by the FDA auditors relative to study management, subject medical records, case report forms (CRFs) or regulatory documentation. ARG's project manager and clinical research associates demonstrated excellent quality and process control, within predetermined budget and scheduling parameters.

The role of TrialVista:

ARG utilized its experienced staff and TrialVista, the company's Clinical Trial Management System (CTMS), to efficiently manage the successful completion of the clinical trial.

“ARG was instrumental in helping us meet our timelines for our BLA submission to the FDA. Their dedicated thorough work in managing difficult vendors, efficient monitoring teams and TrialVista CTMS implementation was a critical asset for us as we prepared for this filing.” — Vice President of Regulatory Affairs & Product Development [name & company withheld]

“Everyone involved in clinical research knows the theory of CTMS is correct and that implementation of a CTMS can drastically improve overall clinical efficiency. However, the reality of the situation is that most CTMS fail to deliver on the promise of improving clinical efficiency.” — Lyle Camblos, ARG co-founder and Managing Partner

TrialVista is the only CTMS entirely designed and developed by clinical research professionals. It operates using proven technology on a highly secure platform. This translates into a system that works how clinical researchers work, with less downtime and no more worrying about lost or compromised data.

TrialVista is 100% modular and completely customizable. Each module can be rapidly tailored to suit the individual needs of the sponsor as well as each individual study, no matter how small. Implementation is rapid and data is available in this system as soon as it is entered. All authorized users — from the sponsor, site, CRO and vendors — have access to up-to-date information, which eliminates concerns about the regulatory status of a problem site, or how much drug is in inventory.

“TrialVista keeps you up to date and in the know. If it's tracked in TrialVista, you can easily create a report to monitor it. When data and information are being monitored across thousands of patients and hundreds of sites, it really helps to be able to runs reports quickly and easily.” — Lyle Camblos, ARG co-founder and Managing Partner