Toxi-Coop
Leveraging Proven Expertise to Simplify Clinical Trials

The present-day contract research organisations (CRO) are stepping up their game to fulfil all the pharma and life sciences industry requirements. However, these companies face a multitude of complications, unexpected challenges, and unforeseen risks while conducting clinical trials. The foremost challenge of CROs revolves around large pharmaceutical, biotechnology, and medical device companies expecting these entities to adapt to the continuous changes in the regulatory environment. The other significant issues are presented by the use of animals for toxicity testing, even though the growth possibility for CRO businesses is arguably in areas of in-vivo animal testing and clinical trial management. In addition to the ethical concerns associated with animal testing, these studies are quite costly, and more importantly, animal models often do not serve as good predictors of responses in humans. Addressing these concerns and disrupting the pharma marketplace by leveraging industry-proven experience, Toxi-Coop, a GLP (good laboratory practice) and ISO 9001 certified European non-clinical CRO, aims to improve the overall clinical studies and the medical product development process. “We are flexible and adaptable to the demands of our clients when it comes to the regulatory as well as other animal testing requirements,” asserts Dr. IstvánSebestyén, scientific director of Toxi- Coop. The company employs in-vitro methods of animal testing that abide by the regulatory guidelines.

Toxi-Coop provides a variety of services to the agrochemical, chemical, and pharmaceutical markets. The company employs physical chemistry testing services to precisely measure the drug concentration in the blood of animals and other parameters that frequently change as an outcome of environmental impact. Toxi-Coop also conducts multiple ecotoxicology studies in aquatic and terrestrial ecosystems for agrochemical registration and industrial chemical notification. Since each chemical has different physicochemical properties and the administration route is complex in case of aquatic toxicology tests, the company chooses the right test medium for the ecotoxicology studies.

We are flexible and adaptable to the demands of our clients regarding the regulatory as well as any animal testing requirements

“While we undertake the clinical trials for our clients, we also ensure a GLP,” adds Dr. Sebestyén. GLP includes a set of regulations governing the operation, personnel qualification, and facility requirements involved in the process of toxicological assessment of drugs and chemicals. Toxi-Coop has a distinct Quality Assurance Unit (QAU) that assures compliance with the existing regulations, thereby giving rise to a GLP. The QAU is responsible for checking or comparing the study plans with the traditional study guidelines andinvestigating the involved procedures to ensure their compliance with the guidelines and SOPs of the company. The QAU additionally needs to compile a detailed graph report for the client that is to be discussed later on. Toxi-Coop continuously stays up-to-date with the ever-changing regulations in order to fulfill the demands of the market.

The Toxi-Coop team comprises of people with 25-30 years of expertise and practice not only in Hungary but in different EU countries. These professionals act as trusted partners to their clients, helping them in every step of the trial. The expertise and extensive experience of Dr. Gabor Hirka, the CEO of Toxi-Coop, also adds to the value delivered by the company to its clients. To continue fulfilling the market needs for new studies, Toxi-Coop has been bringing advancements to its mammalian toxicology, biochemistry, in-vitro toxicity, and other chronic or carcinogenesis studies in laboratories. The company is continuously setting up new laboratories to carry out clinical measurements in Budapest. Alongside, Toxi-Coop plans to keep enhancing the quality of its laboratories with the ever-developing technology advancements.