Frequently Asked Questions - Celsis In Vitro Technologies

How long does it take for me to get a study started at IVT?

We try to get started as soon as possible. You will be contacted within 24 hours of your initial request to discuss study designs. However, before the actual lab work gets going, we need 3 things. First, we need a signed Statement of Work detailing how the study will be conducted. As our studies are customized, this entails extensive communication with the Sponsor, and can take some time. Second, we need to have confidentiality and master services agreements in place. Third, we need the Sponsor's test materials. After that, it's 1 to 3 weeks until the study is underway.

How long does it take to complete a study at IVT?

That depends entirely on the complexity and nature of the study. Some take a week, others require more than a year. However, one of the reasons that our customers come back to us time after time is that they know they can count on us to get them the answers they need as quickly as (and usually considerably more quickly than) anyone else. Having optimized our procedures, we take pride in offering consistently accurate results with one of the quickest turn-around times in the industry.

What kind of data summary or report do I get at the end of the study?

We will fax to you a brief data summary just as soon as we have compiled and run a QC review of the data from your study. About 4 weeks later we will issue a final report describing the study protocol in detail, the results of the study, and conclusions based on the results. Depending solely on the level of GLP compliance you require, this report can range from a concise summary of data findings to an all-inclusive report containing in-process, data, and report audits by our internal Quality Assurance Unit.

Why should I use IVT instead of another contract research laboratory?

If you are looking for breadth and depth of experience with in vitro systems for studying drug-biological interactions, there is no better place to go. No other single organization can provide the range of in vitro services and products that IVT does. You can also depend on the quality of our services, using standard operating procedures refined from years of experience. And if you are like many of our customers who need their projects completed by "yesterday," we can work with you to get you the results that you need fast. Simply put, we are ensuring success by delivering quality.

What does it mean that In Vitro Technologies will conduct your study in accordance with GLP regulations?

In Vitro Technologies has recognized the need to establish a formal quality assurance system. Although not all of the available in vitro technologies in ADME-Tox testing are regulated by regulatory agencies and these in vitro studies are not required to be conducted according to GLP regulations, In Vitro Technologies has put processes and procedures in place that adhere to GLP regulations to ensure the integrity of the in vitro studies and to ensure that the studies are conducted to the highest scientific standards.

Can IVT advise me on what level of compliance is necessary to submit my findings to the FDA?

Yes, In Vitro Technologies has served the drug discovery and development industry for more than 16 years. Our scientific team is readily available to provide guidance to ensure your study is completed in accordance with current FDA regulations.

Can IVT develop an analytical method for my test compound?

Routinely, we develop analytical methods to help you understand the physicochemical and biophysical characteristics of your product. If you already have an analytical method available, you can transfer the method to us and we will qualify the method in our laboratory. We are also able to perform method validation if necessary.

What phases in the drug development cycle does IVT serve?

IVT established its name as the leading provider of ADME-Tox products and services, serving drug discovery and preclinical drug development teams in biotechnology and pharmaceutical companies throughout the world. We now offer a comprehensive program of drug development services to support you from Preclinical through all Clinical Phases. With these services, we provide complete documentation for regulatory submissions, including but not limited to: INDs, NDAs, ANDAs, and BLAs.