Study Design and Protocol Development
Consultation on study design, development of study outlines, development of study protocols that meet ICH E6 and ISO 14155:2011 Good Clinical Practice requirements and guidelines. Specialization in the contact lens and ophthalmic pharmaceutical and device industry. Participant information sheets and informed consent documents can also be generated or customized.
Ethics / IRB Applications
Extensive experience in generating application dossiers for ethical review (Proportionate Review and full Ethical Committee Review) in North America and the United Kingdom.
Professional and Patients Surveys
Development and implementation of online and/or paper surveys to be completed by Eye Care Professionals and/or patients. Surveys may be conducted concerning general questions of interest to the profession and to also to address specific questions which are considered key to the ophthalmic industry. Analysis and interpretation of results and development of survey report(s) and related presentations and publications can be provided.
Identification of study sites and protocol training of site personnel. Monitoring study progress, development of reports etc.
Report and Medical Writing
Kathy has extensive experience in medical and scientific writing and has an extensive list of publications and presentations given at conferences. She is a reviewer for many journals including Eye and Contact Lens, Contact Lens and Anterior Eye, Optometry and Vision Science and Ophthalmic and Physiological Optics. Kathy is a council member of the International Society for Contact Lens Research and served as Chair of the Tear Film and Ocular Surface Society Epidemiology Subcommittee of the Contact Lens Discomfort Workshop. She is currently a member of the Tear Film and Ocular Surface Society Subcommittee on the Diagnosis of Dry Eye.
Scientific Abstracts and Presentations
Kathy has considerable experience in the generation and review of scientific abstracts and in the preparation and presentation of posters and presentations for scientific conferences.
Consulting activities may include review of documents (e.g. protocols, internal reports, manuscripts etc.), and telephone conference calls, meeting with sponsors etc.
Kathy is an experienced speaker and has given more than 200 invited and continuing education lectures at conferences worldwide.