Preclinical Project ManagementLeaders in Drug Development Consulting and Preclinical Project Management
The professional management of a preclinical project or program ensures that scientific and regulatory milestones are achieved, timelines are met and budgets are respected and this is the core expertise of InSymbiosis. An InSymbiosis project manager coordinates the project through the process of CRO selection, protocol and work plan development, protocol approval and sign off, project logistics (compound and sample shipping etc), pre-, during- and post study monitoring, problem identification and resolution, interim data review and draft and final report review and sign off. Throughout the process, the project manager controls and coordinates the flow and approval of all documentation and creates a central repository for all documents which will the facilitate preparation of the regulatory submission. Further, the InSymbiosis project manager coordinates the decision making process by identifying key issues and decisions that need to be made and then ensures that the client responds in a timely manner so as not to unnecessarily delay projects.
InSymbiosis’ multidisciplinary team brings together many years of experience in many areas which include:
- Drug Discovery: Assay development, screening (HTS), lead optimization chemistry, in vitro ADME and pharmacokinetic studies
- Preclinical Development: Pharmacology, safety pharmacology, regulatory toxicology and toxicokinetics, analytical and bioanalytical method development and analysis, ADME studies, GLP study development and compliance
- Chemistry, Manufacture and Control (CMC): Chemical development, scale up and GMP manufacture of active pharmaceutical ingredient (API), analytical methods, stability testing, formulation development and GMP drug product manufacture.
The InSymbiosis team has worked in multiple therapeutic areas including oncology, inflammatory and immune disease, cardiovascular disease and metabolic disease and have worked with various drug types including small molecules, peptides and biologics.