Clinical studies to strengthen OTC products

A new provider of clinical studies and strategic consulting has entered the field to revolutionise the market for over-the-counter (OTC) medicines and related products. Orange OTC Research ( is the first clinical research organisation (CRO) to focus specifically on consumer healthcare in Europe. The company wants to become an initiator of “new, intelligent, scientifically supported product claims”, as co-founder Dr. Stefan Sandner emphasises.

The people behind Orange OTC Research – Juliane Hellhammer from the contract research organisation daacro GmbH & Co. KG, Dr. Stefan Sandner from the pharmaceutical service provider Diapharm GmbH & Co. KG, as well as Dr. Burkhard Breuer and Dr. Marion Breuer from the contract research organisation proinnovera GmbH – are industry insiders. The collaboration brings the partners together to pool their expertise as CROs and consultants with the aim of counteracting the trend towards standardised OTC product profiles in the long term. Their goal is to create new market opportunities for consumer healthcare products through creative study designs and the use of state-of-the-art technology, Juliane Hellhammer explains. “Our OTC studies are based on valid medical and scientific support along with study designs that are customised to meet these products’ special market needs. This is a significant added benefit compared to conventional marketing studies.”

A first for the consumer healthcare industry

The company’s strategic approach and its specialisation as a consumer healthcare CRO for OTC medicinal products and related health products, such as nutraceuticals and cosmeceuticals, is an absolute first in Europe. As a result, Orange OTC Research is playing a pioneering role in making consumer healthcare products a category to take seriously, Dr. Stefan Sandner emphasises. “Through the combination of sound market knowledge, regulatory OTC expertise and customised studies, we are now giving manufacturers the opportunity to position products and brands off the beaten track thanks to innovative claims that are in line with regulatory and medical requirements.”

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