The Monane Group Clinical Consulting, LLC is a firm devoted to delivering deep and ethical professional advice and consultative services to the biotechnology, diagnostics, and pharmaceutical industries. Recent projects on clinical research and patient education have included several therapeutic areas• Performed competitive analysis of drugs for cardiovascular and oncologic diseases• Summarized drug trial results for investor and lay audiences • Advised on patient recruitment/enrollment strategies as well as trial design and conduct • Developed teaching materials on drug development processes

• Reviewed patient data for protocol adherence in Phase 3 trial of investigational diabetes drug • Provided corrective action plan for protocol non-adherence • Prepared patient record and format for final data lock

Drugs studied - Actemra, investigational drug for urinary incontinenceConducted ongoing review of patient data for 1500 patient study pivotal Phase 3 trial for Actemra in rheumatoid arthritis and extension studiesDesigned and conducted recruitment strategies with CROs for Phase 2 trial for investigational agent in urinary incontinenceAdvised sites, monitors and data managers on protocol adherenceProcessed SAE's along with issuing and tracking science queries related to SAE'sServed as contact person for monitors, sites, and Science Team for SAE process

Drugs studied - ProCrit, PulmacortRecruited and enrolled study subjects for approved products for Phase 4 trials in pulmonary and hematology studies, including eligibility screening, informed consent, and patient schedulingParticipated in study protocol development and implementation, including attendance at PHARMA investigator's meetings, agreements with physicians, and budget assessmentsComplied with FDA regulations, including study documentation, laboratory specimen handling, and adverse event reporting

Drug studied – DetrolConducted comprehensive review of clinical literature on urinary incontinenceWorked with healthcare educator to develop patient and physician education materials

Drug studied – investigational drug for infectious diseaseCoordinated Phase 3 pivotal trial for investigational drug for upper respiratory tract infections, including database maintenance, interfacing with other research nurses, and providing reports to study physiciansRecruited patients and directed patient participation in protocolsPerformed chart reviews and phone interviews

Drugs studied – Ditropan, Proscar Provided comprehensive nursing care in the evaluation and management of patients with urinary incontinenceRecruited patients for Phase 4 studies in urinary incontinence and benign prostatic hypertrophyMaintained database on all study subjects

Designed research study to improve medication compliance in the elderlyConducted experiments in ambulatory-care settings of Montefiore/North Central Bronx HospitalsAnalyzed data and presented findings at a national geriatrics meeting

Provided outpatient nursing care as designed by SHEP protocol in Bronx, NYInstructed patients on proper dosages and side effects of medicationsAdministered questionnaires and chart reviews

Provided care to patients with a wide range of cardiac diseases including recent myocardial infarction, congestive heart failure, and arrhythmiasActed as Charge Nurse for a 22-bed unit, administered medication, and provided patient education

Provided nursing care to patients wit a wide variety of medical diagnosis including cardiac, respiratory, oncologic and renal diseasesResponsible for off-shift charge position in a 29-bed unit

Assisted the physician with gynecological examinations and operative proceduresConducted patient education on family planning and breast self-examination