Toxicology specialist guidance, nonclinical safety project design and study monitoring

Safety Assessment in pharmaceutical development

We are primed to support Swedish research and development enterprises in their needs to identify toxicological risks and safety margins in their emerging products. The development of a new medicine is a long and complex process, requiring the interplay of multiple skills to ensure optimal balance between therapeutic effects and potential toxicity liabilities and the delivery of a viable candidate for clinical testing. From a safety perspective, the route to achieving this balance is individual to each project and therapeutic entity, often presenting considerable difficulty to small and medium-sized enterprises sin the face of daunting arrays of potential laboratory studies and risk assessment strategies.

Tailor made development plans

Choosing the correct path and following it swiftly is thus a key to success in valorisation of drug projects. Our senior toxicologists at RISE collectively possess vast experience in designing, scheduling and executing the different activities needed for taking a candidate small or large molecule drug through safety assessment to clinical trials. The proximity of this experienced toxicology support to our experimental facilities and capabilities, including AI-based prediction models, in vitro screening tools, bioanalytical analysis methods and relevant animal models, also ensures short lead-times to key results, further enhancing the valorisation chain.

In-house and outsourced studies

Our in-house studies can be performed in compliance with GLP guidelines where required. If your study does not claim GLP, all critical operations will be performed with high standard and in accordance with local SOPs. For activities we cannot perform in-house, we will coordinate the outsourcing to a Contract Research Organization (CRO) either chosen by the client or a CRO in our network and provide study monitoring of the different activities outsourced.

Regulatory requirements within several areas

Regulatory compliance in safety requirements is paramount in all areas of business development. Our long-standing experience in navigating projects also includes contributing to regulatory submissions in terms of writing nonclinical summary documents, as well as brokering scientific consultation with the regulatory health authorities. 

One point of contact

From A to Z, your project is our project, and the designated toxicologist acts as “one point of contact” towards the client and coordinates all activities. This facilitates the timing, scheduling and keeping the timeframe of the study from your perspective.