Outsourced Research & Development Support for Pharmaceutical Products
To support the full breadth of preclinical (nonclinical) research and development of pharmaceutical products, Paracelsis can help its customers to outsource studies for example studies designed to meet Good Laboratory Practice (GLP) guidelines. Its pharmaceutical outsourcing services include: CRO selection, protocol generation, study monitoring and reporting.
Outsourced Study Types
Examples of outsourced pharma studies are provided below; these studies will usually be pivotal in assessing the risks to human health through exposure to the substance:
- Acute (typically <14 days), Subacute (typically 14-28 days), Subchronic (typically 90 days) and Chronic (typically 180 days in rodents and 270 days in non-rodents) Toxicology studies to investigate adverse effects, reversibility in adverse effects, and toxicokinetics. Subacute, subchronic and chronic studies will usually include a full clinical pathology including clinical chemistry, haematology, necropsy and organ weights, and histopathology. Subacute and subchronic toxicity testing can be performed with full histopathology or a limited/abridged tissue evaluation.
- Safety Pharmacology studies to examine undesirable pharmacodynamic effects of a substance on physiological functions in Primary organ systems (Central Nervous System, Cardiovascular System, Respiratory System) and Secondary organ systems (Gastrointestinal System, Renal System).
- Genetic Toxicology (Genotox) studies to evaluate the potential of a substance to induce gene mutations or chromosome damage using a battery of in silico, in vitro and in vivo test systems. This information is of critical importance since genetic damage can cause an increase in the incidence of cancer or heritable diseases in human populations.
- Carcinogenicity studies to evaluate the carcinogenic/tumorigenic potential of a substance in animal models.
- Reproductive and Developmental Toxicology studies to evaluate adverse effects of a substance on sexual function and fertility in adult males and females as well as adverse effects at any stage in the life span of the offspring that are induced during pregnancy or as a result of parental exposure.
Paracelsis can provide strong scientific input on toxicological study design to meet its customers product development objectives. Study outlines can be prepared, and these can serve as Request for Proposals (RfPs) at the CRO selection stage thereby ensuring parity and facilitating cost comparison between CROs.
CRO selection is critical to the success of an outsourced pharma study since the chosen CRO will usually conduct all of the various study functions leading to a final report that can be used to support a regulatory submission. Therefore, experience in conducting the given type of study, adherence to the protocol and regulatory requirements and generation of scientifically robust data that are accurately reflected in the study report are crucial. When considering pharmaceutical outsourcing, it is important to assess the CROs capabilities and strengths and weaknesses in order to understand how the particular study will be run and how the various departments and functions will interact. This will be instrumental in deciding whether or not the laboratory can realistically meet customer needs and expectations and determining monitoring requirements to ensure that the study is conducted and reported correctly and according to an agreed timeline and budget.
The protocol is a key component of GLP compliance and should address the technical conduct of the study across all functions and cover scientific, logistical, regulatory, and animal welfare aspects. Thus, it is crucial that the protocol is clearly written and understandable to everyone involved prior to its issue.
Upon execution of a contract, between the Customer and the CRO, Paracelsis can provide a monitoring service to ensure high quality study conduct and reporting. In this role, Paracelsis will often serve as an interface between the Study Director at the CRO and stakeholders within its customer’s organisation.
Paracelsis is able to provide comprehensive, expert, review of reports generated by CROs to ensure that the raw data are appropriately reflected and interpreted and to guarantee scientific validity and compliance with the reporting standards of GLP. We will provide scientific input as necessary, for example by comparing findings to the scientific literature or other research findings, to aid formulation of robust conclusions thereby facilitating progression to the next phase of drug development.