Introduction

In the pharmaceutical product development world, we often joke about the old adage that, when planning a project, it would be nice if the work could be “good, fast and cheap”, but that you can only have two of those. Appian’s approach wreaks havoc on this truism, and, in the process, makes it possible for your project to come in on-time, with the highest standards of quality and within an extremely competitive budget.

In our model, the ultimate goal is to provide support for a successful marketing application, from ANDA to NDA. We achieve this goal through careful study design, efficient implementation of the protocol, continual feedback from investigative sites and proactive approaches to monitoring and data management.

Our experience is second to none. Having developed over 140 clinical protocols and managed many of these projects to completion, we understand that each product brings with it a unique set of needs and challenges. Clinical endpoint bioequivalence studies are complex, time-consuming and expensive undertakings, and our experience greatly improves the likelihood of a successful drug development program.

We have a wide variety of time-tested methods in place that will allow us to rapidly mobilize to launch your project. Combined with our constant innovation to improve the industry status quo, our approach reflects both our extensive experience in clinical development and the current status in the ever-changing world of regulated industry.

The Appian Way of designing and managing a trial is refreshing, intelligent and effective. Efficient communication at every stage of the project is key. From the moment your contract is executed through the submission of your application and beyond, we work to ensure that your team is on top of its project, that reports to your management reflect accurate projections and that the study moves forward within timeline and budget constraints.

In a period in which human subject protections are of great concern, Appian takes pride in its spotless record of compliance. We proactively review the ethical issues of each project, provide expert opinion and regulatory support, and closely monitor investigative sites to ensure that your study is conducted under the highest standards of Good Clinical Practices. And in multinational studies, we have time-tested methods of overseeing non-US facilities to dramatically reduce the potential for substandard performance.

The following pages outline a few advantages of working with Appian. We hope that you find them informative and helpful in making your CRO choice. As always, we are available via phone or email for specific inquiries.