Background Information and Principal
Scientific and Technical Evaluation of Pharmaceuticals, Inc. (STEPh, Inc.), was formed in 2005 by a group of pharmaceutical industry veterans, and each has over 25 years of experience within Medical Affairs and Commercial Operations in large pharmaceutical companies. STEPh Inc., is a medical communications company that specializes in the provision of Competitive Intelligence reports (referred to as STEPh REPORTS) and an array of medical writing services such as manuscripts for publication, product monographs, and medical information standard response letters.
The founder, Dr. Jay H. Bauman, has a vast background that spans hospital clinical practice, and numerous industry Director level positions in medical information, regulatory affairs, competitor intelligence, and strategic marketing.
Dr. Bauman has authored more than 30 publications in the medical, pharmaceutical, and trade literature. He is also a past Editor of the Hospital Edition of US Pharmacist, a founding member more than 20 years ago of the Medical Communications subgroup within the Drug Information Association, and has 20 years of experience in the art of competitive intelligence. He has been a requested speaker at numerous pharmaceutical society meetings.
STEPh Inc. is a unique company in that its principals all have extensive experience as both users and providers of pharmaceutical consulting services. Therefore, we understand the needs of our clients and are able to tackle projects in a quick and timely manner. As a small company with limited overhead, we are able to provide personalized services at a reasonable and affordable price and function as an extension of the department to which we provide services. We offer a single point of contact and are available whenever issues arise.
One of the signature services that STEPh Inc. offers are Competitive Intelligence Therapeutic Area Reports (known as STEPh REPORTS) and tailored Competitive Intelligence projects. Each of the therapeutic area reports represent a timely review of drugs in development in selected disease states. Information is presented according to mechanism of action, phase of development, and potential year of approval. Reports include summaries of relevant clinical and preclinical data and are kept current and updated every other month. New information is easily identifiable from previous versions. What differentiates these reports from those offered by other providers of Competitive Intelligence is that the reports are always up-to-date and fluid and can be tailored to the individual needs of the end-user.
In addition to the individual therapeutic area reports, STEPh Inc. also provides a question and answer feature, daily and weekly news for each disease state, and brief summaries of selected “hot topics”. This service is available by yearly subscription at a very affordable and competitive price. STEPh Inc. also attends scientific meetings and can provide reports of selected meetings at a nominal charge. In addition, STEPh Inc. is well positioned to conduct primary research on virtually any scientific topic. STEPh Inc. adheres to the Code of Ethics as described by SCIP.
Dissemination of scientific information through published means is an important follow-up to the conduct of clinical trials. STEPh Inc. has an impeccable track record for acceptance of all types of manuscripts (e.g., those reporting on results of clinical trials, review articles, editorials, letters, and continuing education articles) to scientific journals. A typical manuscript can be drafted within 4 weeks. If required, STEPh Inc. can also manage the whole manuscript process from creation to submission and review, as well as selection of a target journal. We do not consider ourselves as medical writers but rather as clinicians who can analyze information and present it in a clear and concise manner.
Members of STEPh Inc. have been involved in the creation of medical information standard response letters for dozens of product launches over more than 30 years on both the national and international levels. One of the main objections to standard response letters is that they are too long and the answers are not readily identifiable. We understand how to craft fair-balanced responses that are informative and easy to read and have led workshops on this topic at society meetings. We specialize in the support of new product launches but also have extensive experience in the revision of standard response letters for established products. We can provide this support function for single queries or an entire database of responses at a very modest price.
Product Monographs represent an extensive summary of the preclinical and clinical data generated to support approval of pharmaceuticals. These can be challenging and time consuming to create. STEPh Inc. takes pride in its ability to distill large amounts of data into a very readable document. A first draft of a typical product monograph can be crafted within 3 months according to the specifications of its clients.
We Are Different
Given that we have been both consumers and producers of the services we provide, we understand the needs of our clients. Further, as a small company we are able to provide high quality, timely services at very affordable prices.
We at STEPh, Inc., are very excited to launch our new website and introduce our services and capabilities to you. Feel free to contact us by either email or phone at 800-280-7015 for more information about any of the standard or tailored services we offer.