New German-based CRO Enters OTC Sector

A new provider of clinical studies and strategic consulting, Orange OTC Research, aims to shake up the market for over-the-counter (OTC) medicines and related products.

The company claims to be the first clinical research organization (CRO) to focus specifically on consumer healthcare in Europe, and hopes to become an
initiator of “new, intelligent, scientifically supported product claims,” according to co-founder Dr. Stefan Sandner, from the pharmaceutical service provider Diapharm GmbH & Co. KG.

The other people behind the venture are ­Juliane Hellhammer, from the
CRO daacro GmbH & Co. KG, and Dr. Burkhard Breuer and Dr. Marion Breuer from the CRO proinnovera GmbH.

The partners intend to pool their expertise as CROs and consultants with the aim of counteracting the trend towards standardized 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, explained Hellhammer.

“Our OTC studies are based on valid medical and scientific support, along with study designs that are customized to meet these products’ special market needs. This is a significant added benefit compared to conventional marketing studies,” she said.

The company’s strategic approach and its specialization as a consumer healthcare CRO for OTC medicinal products and related health products, such as nutraceuticals and cosmeceuticals, is a first in Europe, according to the partners. As a result, Orange OTC Research is playing a pioneering role in making consumer healthcare products a category to take seriously, Sandner added.

“Through the combination of sound market knowledge, regulatory OTC expertise and customized 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.”