Clinical protocols are the heart and soul of the clinical development program. Jerry Eisen of Eisen Medical Writing (EMW) understands that a superior clinical protocol is objective-oriented and written with precision and full integration of each element of the clinical research study that is to be defined by the protocol. Medical research protocols differ widely in their scope. Protocols for drug studies differ markedly from protocols for biologics or medical devices. Protocols for Phase I clinical trials will differ significantly from Phase III clinical trial protocols and likewise, efficacy and safety clinical trial protocols will differ significantly from protocols that define pharmacokinetic or pharmacodynamic clinical trials. Clearly, every clinical trial is different and frequently, medical writers who lack clinical development experience can struggle when writing clinical protocols.
During Jerry’s 20 years developing new drugs, medical devices, and biologics, writing clinical protocols was a primary responsibility and extended across a wide-range of therapeutic areas. As a contract medical writer, this experienced has served Jerry well and is the basis for Jerry’s scientific and medical understanding of many therapeutic areas including but not limited to oncology, immunology, allergy, cardiovascular diseases, dermatology, autoimmune diseases, neurological diseases, hematological disorders, abdominal surgery, orthopedic surgery, metabolic disorders, and enzyme replacement therapy.
In terms of writing clinical protocols, a solid background in clinical development combined with extensive medical writing experience argues convincingly that EMW is the right choice for the discriminating client.