ARG

Pivotal Phase III Trial Undergoes Audits by the FDA and Sponsor

Challenge:

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 and a complete audit by our sponsor. The BLA submission for C1 inhibitor has been made to the FDA and approval was granted in 2008.

Results:

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.

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.

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]

Lessons Learned:

Obtaining good clinical data from investigative sites is only achieved by having the best-trained, highly motivated and dedicated staff that put a focus on relationship building. ARG's clinical teams are thoroughly prepared for regulatory inspections and every member of our project management staff understands that the value of our results is only as good as the data that harvested at our clinical sites. Every project ARG takes on is with the understanding that it must meet all regulatory requirements and must pass our internal compliance checks to ensure success.

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.

ARG Successfully Starts Up A Phase II Trial Within 6 Weeks

Challenge:

In an economic downturn, small biotech companies often depend on clinical milestones in order to maximize shareholder value and drive market direction. This means that their CRO must completely understand and be aligned with the sponsor's corporate objectives. Meeting an aggressive timeline on a challenging protocol is a significant driver of share price and market perception.

Results:

ARG successfully started a Phase II intradialytic hypotension trial and enrolled the first patient within 6 weeks of contract signature. Using TrialVista, ARG's proprietary CTMS, the implementation of all study start–up activities, from investigator recruitment to investigator product supply, was streamlined — and, based on its advanced approach to project management, several steps were significantly reduced or even eliminated.

ARG was able to simultaneously get all the trial materials developed, finalize CRF design and collaborate with qualified investigators to ensure FPI (first patient in) deadlines were achieved ahead of schedule.

ARG has been ahead of every study metric since the FPI deadline and completed enrollment on this 15 center, 75 patient trial on time and on budget.

The combination of services and software:

“ARG was able to go from contract to enrolling the first patient in an incredibly short period of time. We are extremely pleased to be working with them on this trial and are excited about being able to utilize TrialVista throughout this study” — Clinical Operations Manager & Product Development [name & company withheld]

Lessons Learned:

It is critical that your CRO understands the corporate goals of its sponsors and adjusts their resources to meet the demands of the study. Aggressive timelines are some times unrealistic, but at ARG we thoroughly evaluate each component, apply the best and correct amount of resources needed to meet or exceed our client's needs.

By utilizing TrialVista, and ARG's experienced clinical management team, sponsors are ensured of several things:

• Rapid Implementation
• Total Team Involvement
• Precise Monitoring of Key Trial Parameters
• 24/7/365 Support