• produce high quality, protocol compliant data, accurately recorded and documented by source documents that are readily available for compliance and data audit;
• Contract with experienced (10+ years) clinical monitors, statisticians and auditors that you can rely on to complete the monitoring and auditing of the clinical trial throughout its duration, at the clinical site or at the company office, as directed, and use this experience to meet Corporate time and budget goals;
• have essentially no overhead to increase the costs for contracting the research beyond reality;
• use a dedicated and experienced project director that would be managing your project for its duration;
• invoice monthly for the actual time the monitors and auditors spend on your project rather than 1/12 of the annual cost estimate on a monthly basis, followed by BALLOON payments;
• be able to be reached via phone or pager throughout the day avoiding voice mail and call backs, telephone tag and the like;
• communicate with you on an ongoing basis, not only when you ask for something;
• be a member of your development team adding value to the project, based on our experience, as we go along.
• Recently celebrated our 10th year in business

My company is small and I intend to keep it that way. I only manage one-two major clinical trials at a time allowing me to dedicate the time and effort required to ensure success. As such, I maintain a negligible overhead. With no offices in Europe, Asia or multiple offices throughout the U.S., no large facilities or mortgages to pay, I pass these savings on to you. Typical overhead for other CROs are equal to or greater than the fee for the monitor! I often read about the millions of dollars of profit that large CROs report annually. These large publicly held companies have administrative costs that add substantially to their overhead and, in turn, to your costs. I have no stockholders who are seeking high annual returns on their investments. I have no such overhead and these savings are realized by my client companies. We have no advertising costs; our work frequently results from "word of mouth" from satisfied clients and referrals. I am often reminded that bigger is not always better; after all, Michael Jordan was the 242nd tallest player in the NBA!

I personally direct each clinical program. I answer my own phone thus allowing for rapid communication. Everyone on your development team has direct access to me, and the staff, and the data. I ask that each CRA provide me with copies of the CRFs that have been reviewed at each monitoring visit. I review each one and provide my comments directly to the monitor. I can provide written updates to you on a weekly or monthly basis, as you desire, regarding the number of patients enrolled at each site, the number on active treatment and the number of patients completing the trial as well as the number of patients evaluable according to the protocol requirements. With large trials in which we have been involved from its inception, we commonly write a monthly "newsletter" to each site providing timely information on enrollment status per site, as well as "reminders" resulting from monitoring or audit findings. These newsletters go a long way towards keeping your study at a high priority at these busy clinical sites.

We provide a consolidated monthly invoice, including each consultant providing service, during the period. This invoice is detailed enough to allow you to determine where your money is going. Typically, it includes the number of hours the monitor and auditor spends in travel and at each site, the number of hours spent by me in managing the project and in reviewing the CRFs, the time spent in setting up the data base and in data entry, the time the statistician spends in analyzing the data, and the medical writer's time in preparing the clinical report, should these services be required. I distribute the funds I receive from you to each contractor in a timely fashion. Each consolidated monthly invoice includes the individual contractor's statement of hours including the sites involved, as appropriate. As you have previously approved each contractor's rate, you have a management tool to control your budget. Should you wish to eliminate a non-producing clinical site, these savings will become immediately apparent as no further hours will be billed after close out of that site. Should you wish to replace that site, the time spent in this effort will appear on the next monthly invoice.

I am readily available for team meetings, scheduling discussions or management review of the program as needed. This eliminates the need for long lead time associated with scheduling due to travel. Your QA staff are welcome to review the quality of each site as you require. Monitoring and auditing reports are available for your review at any time and are always included in the study file. As I maintain a complete record of data of each patient and site in my office, you are welcome to visit at any time.

My clients that have used contract services from major CROs or in-house clinical staff find that the services I provide are not only unique but are cost effective and timely as well. I am told that our services are at least 20% less costly than the larger CROs that my clients have used in the past. As in-house monitoring and auditing staff spend only 40% of their time actually monitoring or auditing at the site, you can see how these services rapidly become cost and time effective.

As management is commonly the end user of the clinical data provided, you have a critical interest in the timeliness and quality of the trial conducted and the data reported. Much of my work results from discussions I have had with the highest levels of the corporate structure who can see the benefits that this process provides and recommends us to conduct and manage these clinical programs. Others call us after they dismiss their current CRO due to poor quality performance, lack of timeliness and overly excessive costs. Some of my major clients include Bristol Myers Squibb, Baxter Healthcare, Biogen, Syntex, Abbott Laboratories, Unimed Pharmaceuticals and others who value their development dollar. These companies and others have seen the value of outsourcing the resource-intensive clinical and regulatory process rather than continuing to seek clinical staff and absorbing search fees, relocation costs, CRO overhead and the like.

Should you like additional details on how I would manage your most important clinical trials, please telephone. I know that the monitoring and auditing of clinical programs will be a major undertaking for the Company and is of great importance to the commercial success of the products. As such, I need to plan well in advance, as you do, to ensure that I will provide the quality service that my clients have come to expect.

Sincerely,                          

Clifford Siporin