Strategic Consulting for the Biomedical Industry

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Thomas Laage Consulting provides physician services to the medical device, pharmaceutical, and health care marketing industries on a contract basis. Clients include clinical research organizations, start-up companies, and established firms. If your company does not have physicians on staff to provide a medical presence or medical expertise in clinical, regulatory, or commercial matters, Dr. Laage offers these services on an as-needed basis, in a cost-effective and reliable manner.

Thomas Laage, MD, MPH

About Us

Dr. Laage is a physician consultant in the areas of clinical trials, medical safety, pharmacovigilance, medical direction, medical affairs, and strategic direction. His clients are contract research organizations, medical device and pharmaceutical companies, and other consulting groups or firms needing physician input. He is able to listen carefully, consider thoughtfully, and then add the doctor's perspective, whether in clinical trial reporting, marketing message, or corporate mission. When your audience is physicians, whether in practice, at the FDA, or among clinical investigators, he speaks their language.

Dr. Laage practiced for many years as a specialist in psychiatry, where the most important clinical asset and diagnostic tool is the ability to listen. The next most important asset in that field is the ability to speak the truth with clarity in a manner that is pleasing, beneficial, and non-agitating, always aiming to foster and strengthen the alliance or relationship. Whether the "persons" across the table are consumers, prescribers, regulatory agencies, marketing or public relations firms, supervisors, subordinates, or members of the press, they want to know the truth, they want to think well of themselves, and they want to think well of you. The truth has the power to unify but how the truth is told makes all the difference.

Dr. Laage has written and published in the medical literature but has also helped to write mission statements and marketing copy for non-profit organizations, as well as didactic materials for seminars, retreats, and adult education classes which he has conducted on a wide variety of topics, including psychiatry, philosophy, music, art, and the Sanskrit language. In the clinical trials area, he has helped to review protocols, write synopses for clinical reports, construct detailed reviews of topic areas in the medical literature, compose clinical study reports and clinical report forms, and edit serious adverse event narratives and medical manuscripts for publication. He is familiar with the standards for reporting of clinical trials, including the CONSORT criteria and trial registration, and with journal requirements for manuscript submission. He is conversant with FDA guidelines for disclosing and presenting consumer information, for reporting pre-market and post-market adverse events, for REMS, and for NDAs and IDEs, as well as with the associated ICH guidelines for Good Clinical Practice, Clinical Study Reports, Clinical Safety and Expedited reporting, and Pharmacovigilance.

Dr. Laage is married and lives with his wife in the New England town of Concord, Massachusetts. He has been in the physician business for many years as a self-employed practitioner and consultant, providing a standard of availability, affability, and ability that has translated into many satisfied clients. He was board-certified in both Internal Medicine and Psychiatry for many years, having completed residencies in both. Recent highlights have included completing a Masters in Public Health at the Harvard School of Public Health, working on FDA approval for the Medtronic Cryocath intravascular catheter for atrial fibrillation cryoablation, consulting to a disinfectant products company about a potential tie-in to the cleanliness habits of the general public across a range that included compulsive personality traits and obsessive-compulsive disorder, and performing Expert Scientific Reviews of medical manuscripts to sharpen their focus and presentation for publication. He plays golf and meditates indifferently, in both senses of the word.