Comprehensive Program Management Clinical Development Consulting Clinical Trial Protocol Development Project Management, Monitoring and Auditing Medical Writing Regulatory Consulting Data Management and Biostatistics Electronic Submissions and Labeling International Clinical Trials Our team has extensive expertise in designing and conducting clinical endpoint bioequivalence trials for a variety of topical and locally-acting generic products.  Our team has written protocols for the following indications, among others: Acne Rosacea Acne Vulgaris Actinic Keratosis Atopic Dermatitis Bacterial Conjunctivitis Bacterial Vaginosis Condyloma Acuminata Dry Eye Syndrome Herpes Labialis Hypogonadism Icthyosis Vulgaris Non-Small Cell Lung Carcinoma Onychomycosis Oral Candidiasis Pediculosis Capitis Plaque Psoriasis Scabies Infestation Tinea Capitis Tinea Pedis Tinea Versicolor Vulvovaginal Candidiasis   Our experience in the area of generic drug development allows our clients to take advantage of the most up-to-date information available from the FDA and other regulatory agencies, reducing protocol and application review time and ultimately speeding the approval process.  We are currently working with the Office of Generic Drugs on a protocol review initiative which promises dramatic reductions in review times.     Pharmaceutical Industry News

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