Frequently Asked Questions - Company

1. How long have you been in business?

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2. Where are you located? Do you have clients outside of your geographic location?

Our clients are located across the United States, Canada, Europe, and even in South Africa. We have extensive experience working with groups located near and far and know how to effectively communicate and work across multiple time zones.

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3. How large is your company? How many people do you employ?

Our company consists of nine employees, all of whom are also owners. Each employee-owner therefore has a vested interest in keeping each and every client completely satisfied.

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4. What medical qualifications do your coders have?

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5. Is your coding ever done by contractors?

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6. Is it possible to conduct a site audit?

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7. I already have my CROs performing my coding. Why should I use ThesIS?

Many CROs that offer coding do not have sufficiently qualified personnel. Legacy dictionaries such as COSTART did not require much medical knowledge or experience. With the complexity and specificity of MedDRA, however, coding personnel must be medically qualified as well as highly experienced with the dictionary.

Furthermore, if you have multiple CROs coding your data, a term that is reported to more than one CRO ends up coded by each CRO, rather than having that term coded once with the coding shared by all your CROs. First, this redundant coding is highly inefficient and unnecessary. Second, having multiple sources of coding dramatically increases the likelihood that the same or like terms are not being coded consistently. Even if all of your CROs are diligently following the same coding conventions, there is no guarantee that the same term is coded exactly the same by all of your CROs. With multiple CROs coding your data, you will encounter difficulties when pooling that data.

By having ThesIS code your data:

• You will have a centralized source of coding done by some of the most experienced coders in the industry.

• You will pay only once for a term to be coded, regardless of the number of times that term has been reported across your studies (or across your entire company).

• You will eliminate difficulties with pooling data caused by inconsistent coding.

• You can be confident that your coding is being done accurately, consistently and cost-effectively across your entire company.

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8. What makes you better than other coding companies?

ThesIS stands out from other coding companies in many ways:

• All coding is done by our regular employees. We are not a "virtual" company that gets a coding job and then tries to find the personnel to fulfill the job. We never subcontract coding to someone else, nor do we ever use temporary employees. Your coding is always done by the same, established team of ThesIS coders.  Our team approach means that you get accurate and consistent results every time.

• Our coders average more than 16 years of coding expertise and are among the best in the industry. Every coder is a medical professional with years of practical medical experience working in hospitals and/or clinics. You will be hard pressed to find a better group of medically qualified, dictionary-proficient coders.

• We have used MedDRA in clinical trials since 1997 (the MedDRA 1.5 beta version). Most early adopters of MedDRA have used it only for drug safety. By using it early on for coding clinical trials, we have had many years of experience developing and refining practical techniques for effective MedDRA coding and versioning on a large scale.

• We offer a complete versioning service for both MedDRA and WHO Drug that is far and away the best in the industry.

• Our coders utilize arguably the best and most powerful thesaurus system available. Our proprietary software is not an autoencoder but a complete and extremely powerful system for coding and versioning. We combine expert staff with unparalleled technology to achieve the best possible results.

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