Rx-to-OTC Switch Studies

Trends toward increased self-care combined with the expiration of drug patents means more pharmaceutical companies are considering Rx-to-over-the-counter (OTC) switches to maximize product life cycles. PPD’s consumer health team specializes in Rx-to-OTC switches as well as OTC product testing and development across multiple therapeutic areas.

Our extensive OTC research experience, supported by global resources, helps clients to:

• Facilitate product launch and market acceptance
• Build OTC brand value and maintain category leadership
• Optimize development cycle time
• Support compelling claims

Program Management

Our comprehensive set of services to provide complete management of Rx-to-OTC switch and OTC product development and testing needs include:

• Protocol and case report form (CRF) design
• Label trials
• Actual use trials
• Mall intercept studies
• Consumer product evaluation studies
• Economic and market share assessment
• Submissions preparation

Claims Substantiation

Our expertise in research design, product evaluation and claims substantiation enable PPD to assist clients in developing and implementing successful claims support programs. Our centralized implementation and communications approach helps clients achieve multiple marketing and research and development objectives.

Information that resonates with consumers plays a key role in claims development, acceptance and positive feedback. PPD’s consumer health team designs and implements registry studies that meet scientific, marketing and regulatory needs by collecting real-world consumer information for:

• Marketing claims
• Consumer acceptance
• FDA-mandated studies
• Safety surveillance
• Exploration of new indications
• Product performance
• Packaging or stability issues
• Trend identification

Safety and Efficacy Assessment

When a product is being switched or modified to include new raw materials, additional subject population safety or efficacy studies are often required. With extensive trial management experience, PPD can quickly mobilize for these studies, with resources that include:

• Capacity to expedite difficult or high-volume subject recruitment efficiently
• Access to a large, proprietary database of experienced consumer health investigators and investigator organizations specializing in consumer product testing
• Integrated trial management services
• Sophisticated use of technology to ensure rapid study start-up, conduct and closeout

Integrated Services

PPD’s consumer health team offers a broad range of services to support Rx-to-OTC switches, including:

• Pharmacovigilance
• Medical writing
• Direct-to-consumer