Our services involve a series of experiments and tests conducted on animals, tissues, and cells to evaluate the safety, efficacy, and pharmacology of a new drug or treatment before it enters clinical trials. Our organization takes lead in every step of the pre-clinical study. We provide a vast range of animal testing starting from animal housing all the way to data collection before clinical trials.
Our primary goal of pre-clinical trials is to identify potential safety concerns along with maintaining animal rights throughout. Animal welfare includes moral principles grounded in the belief that non-human animals deserve the ability to live as they wish, without being subjected to the desires of human beings. Animal safety is highly integrated at Orcitrials. We as an organization take great responsibility to ensure humane working in our pre-clinical trials making sure no animals or subjects are harmed in any way. The WMA Declaration of Helsinki requires that biomedical research involving human subjects should be based, where appropriate, on animal experimentation, but also requires that the welfare of animals used for research be respected.
We offer services through all stages of preclinical studies as below:
- Study protocol: Outlining the objectives, design, methods, and statistical analyses of the pre-clinical study.
- Investigator brochure: Summarizing the drug substance or treatment and its characteristics, including any known or potential risks.
- Animal welfare protocols: Outlining ethical guidelines and procedures for the care and use of animals in the study.
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Standard operating procedures (SOPs): Describing the standard procedures and protocols to be followed during the study.
- Study Logbook: Recording all details of the study, including experimental design, data collection, and data analysis.
- Case Report Forms (CRFs): Documenting the individual data points for each animal.
- Sample Storage and Analysis Records: Documenting the details of samples collected and analyzed during the study.
- Quality Control and Quality Assurance Records: Documenting the procedures and processes for ensuring the accuracy and integrity of the data generated.
- Final Report: Summarizing the results of the study, including statistical analyses and conclusions.
- Regulatory Submissions: Providing the results of the pre-clinical trials to regulatory authorities for review and approval before advancing to clinical trials.
- Data retention: Storing all study-related documents and records for a specified period, as required by regulatory authorities etc.
