To date, Covance has been involved in more than 20 REMS projects for drugs in a broad range of therapeutic areas. Our experience ranges from relatively simple Medication Guide REMS to the most complex restricted distribution programs. The following are selected examples of our involvement in various stages of the REMS process.

Pain management

• Advisory Boards, RiskMAP design, and REMS development
• Consulting and preparation for FDA Advisory Committee meeting
• Consulting on REMS submission
• Design, development, and implementation of Elements to Assure Safe Use (ETASU) REMS
• Revision of survey protocol, revision of surveys, and evaluation for three-year assessment
• Evaluation of RiskMAP tool analysis

Severe nodular acne

• Design, development, and implementation of ETASU REMS

Dupuytren’s contracture

• Consulting on REMS submission, design, build, and operations

Hereditary angiodema

• Consulting on REMS submission including survey design, development of survey protocols, and evaluation

Pulmonary arterial hypertension

• Program evaluation and recommendations

Gastroesophageal reflux disease

• Design of REMS protocol, evaluation

Multiple myeloma

• Stakeholder survey, preparation of FDA reporting

Myelodysplastic syndrome (MDS)

• Stakeholder survey, preparation of FDA reporting

Hyponatremia

• Consulting on REMS assessment, data analysis, report creation

Adult chronic immune thrombocytopenic purpura (IDP)

• Complex data collection, integration of multiple service providers

Pulmonary infection

• Development of REMS, survey protocol, surveys, evaluation

Hypogonadism

• Development of REMS submission

Major depressive disorder (MDD) and generalized anxiety disorder

• Recommendations for potential REMS Medication Guide and Communication Plan