Clinical and/or Research Service Companies*
Concentrics Research, an IQVIA business – Specializes in providing research services to pharmaceutical, nutritional/dietary supplement, and medical device companies. A recognized leader in the Rx-to-OTC switch services industry with expertise in the conduct of phase III and IV clinical trials, actual use trials, volumetric forecasting, sensory testing, OTC label comprehension testing, Rx label and package insert comprehension testing, and consumer user-oriented marketing research. The creative design team consults with each client to provide effective solutions for research needs. Multi-center studies: we use an extensive pre-screened site database to assess each opportunity. Clinical trials: the site offers full medical staff, laboratory collection abilities, and multiple examination rooms. Consumer studies: we offer one-way viewing, audio and video recording, and the capability for block enrollment.
Eurofins Food, Feed & Supplement Testing: Eurofins US Food, Feed, and Supplement Testing operates a nationwide network of more than 30 ISO 17025 accredited third-party testing laboratories. Eurofins is uniquely positioned to help your company get your supplement and OTC products through every stage of your product’s lifecycle. We can support you with product release testing under 21 CFR Parts 210 and 211 GMP regulations, stability testing to help determine your product’s appropriate storage conditions and expiration date, product surveillance testing to ensure safety throughout your products lifetime, and R&D support to assist you in the development, validation, and support of new methods that help bring new products to market faster.
KGK Science, Inc. – KGK Science is a premium contract research organization offering high-quality clinical trials and expert regulatory support for the natural health products, cannabis, hemp, and psychedelic industries. Since 1997, KGK has successfully helped hundreds of companies with custom-designed trials and regulatory planning to enter new markets. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of experts, KGK remains at the forefront of our industry, consolidating scientific, clinical, commercial, and regulatory expertise with innovation and agility to serve the expanding needs of global businesses and consumers.
KGK Science offers the following services:
• Pre-clinical services
• Clinical trial design & execution
• Clinical research & regulatory consulting
• Gap assessments
• Path to Market
• Regulatory risk assessment of products and/or ingredients
• Safety dossiers & toxicity assessments
• Claims substantiation files
• Pharmacovigilance
PEGUS Research, Inc. – A full-service CRO with broad experience in a wide range of studies to evaluate the suitability of a drug for an OTC switch. Provides consultation about the feasibility of a switch and design and conducts the studies generally needed for a switch. This commonly includes one or more label comprehension studies, a self-selection study, and an actual use trial. Uses pharmacies as enrollment sites for SSS and AUT work because they most closely represent the circumstances in which people select an OTC drug. Designs studies to assess consumer use of a drug under OTC-like conditions. We use a sample of prospective users who choose and use the drug as they usually would if the drug were already available without a prescription. This development model has been used in successful consumer product campaigns in the US and the UK. PEGUS also conducts specialized safety surveillance trials and undertakes other research studies which require novel research methods.
PPD Inc. – As a global provider of clinical development and laboratory services focused on operational excellence, we improve health by helping customers deliver life-changing medicines. Patients are always at the heart of our work. We deploy our passion, innovative spirit, and exceptional span and quality of solutions to demonstrate the effectiveness, safety, and value of new therapies. This drives us to continually reimagine – and reformulate – the future of pharmaceutical product development.
Radicle Science – Radicle Science is the first-and-only proof-as-a-service company. It offers history’s first easy path for non-pharmaceuticals to clinically prove their actual effects beyond placebo and close the Proof Gap. Radicle Science leverages an AI-driven, crowdsourced, virtual, and direct-to-consumer (D2C) approach, enabling research across diverse populations and conditions at unprecedented affordability, speed, and scale. The B-corp’s Radicle vision is an abundant future where democratized access to clinical trials transforms supplements into proven personalized medicines accessible by all without gatekeepers. To learn more about Radicle Science, visit www.RadicleScience.com.
*Not all companies from these categories may be listed; the “Spotlight” series will highlight different CHPA Associate member companies in a category on a random, rotating basis.