Our Services

InSymbiosis, as a result of our virtual CRO (vCRO) model is able to offer our clients with a “one-stop-shop” experience for drug development outsourcing. Further, our model allows the complete customization of programs for our clients, which is only truly possible via using a vCRO approach. Our services range from early discovery through to Phase II/III clinical studies. By clicking on the chevrons in the diagram below you can find out more about our services.

• Chemistry, manufacture and control

  InSymbiosis offers a full range of GMP and non-GMP services in Chemistry, Manufacturing and Control (CMC) from synthesis of active pharmaceutical ingredients (API) to manufacturing of clinical trial material (CTM) for all stages of development. Our unique vCRO model allows our clients to benefit from our in-house CMC expertise as well as that of our network of contract manufacturing organization (CMO) partners.

  InSymbiosis has the capability of conducting development and manufacturing for both drug substances and drug products. Through our CMO partners, we offer services for the development, scale up and manufacture of drug substances including small molecules and biologics. We offer formulation development, process scale up and manufacturing services for drug products covering a wide range of formulations such as tablets (immediate, delayed or sustained release), capsules (dry or liquid filled), granules/powders, parenteral, liquid, suspension, inhalation (DPI and MDI) and pediatric. We also provide the entire range of analytical services to support drug material characterization and development activities as well as release and stability testing of drug substances and drug products. In addition, we have partners capable of performing packaging and distribution of clinical trial materials worldwide.

• Drug Discovery

  Through combination of InSymbiosis’ drug discovery expertise and our network of discovery stage vendors, InSymbiosis can set up and execute drug discovery and hit-to-lead services and discovery collaborations. InSymbiosis have experience with multiple drug target families and the coordination of integrated biology and chemistry efforts through either high-throughput screening approaches or more focused medicinal/discovery chemistry strategies. With experience in target cloning, cell line generation and assay development, InSymbiosis can support all of aspects of a drug discovery program.

• Lead Optimization and efficacy models

  InSymbiosis’ lead optimization experience allows us to rapidly transition lead compounds to candidates ready for formal preclinical IND enabling studies. Our network of experienced vendors allows us to offer our clients a full range of lead optimization services including in vitro ADME profiling, pharmacokinetic studies and bioanalysis, hERG testing and other cardiovascular safety assessments. Further, through access to a range on animal models via both CRO and academic collaborations, InSymbiosis is able to provide animal proof of concept studies across a wide range of therapeutic indications.

• Non-clinical safety studies and bioanalysis

  InSymbiosis has a vast amount of experience performing non-clinical GLP compliant toxicology and safety pharmacology programs to enable IND/IMPD as well as NDA submissions. Via our seasoned and experienced toxicology team, our client’s studies are placed at well-respected, GLP-compliant non-clinical CROs that have undergone rigorous audits by the InSymbiosis Quality Group. From the planning stage of a program through to the regulatory submissions, InSymbiosis offers a comprehensive service that includes study strategy and planning, protocol development/review and finalization, study monitoring during all critical study stages and report review and finalization.

  InSymbiosis and our vendors have significant experience performing toxicology studies for all compound classes across all species (including non-human primates) and administration routes (oral, intravenous/infusion, intraperitoneal, intramuscular, dermal, inhalation, intrathecal, epidural, intracerebral and intravitreal). Further, with validated study durations covering acute, subchronic, chronic and carcinogenicity, InSymbiosis can support drug safety assessment through to NDA submissions.

  In addition, to complete the IND/IMPD package, InSymbiosis provide genetic toxicology services, as well as a comprehensive battery of safety pharmacology assessments for CNS, respiratory and cardiovascular safety assessments.

  Bioanalysis, a crucial part of non-clinical studies, is also a key strength of InSymbiosis. From development of bioanalytical methods for all molecule classes (small molecules, peptides, proteins and antibodies, antisense etc), through to their GLP validation and sample analysis, InSymbiosis is well positioned to support all of our clients bioanalytical needs. In addition, InSymbiosis have significant experience developing and validating anti-drug-antibody assays through to their effective incorporation into non-clinical programs for biologic compounds.

• Regulatory

  InSymbiosis provides regulatory support to our clients by leveraging internal expertise. Our scientific experts have significant experience in designing non-clinical toxicology programs to support regulatory filings worldwide. They can also provide guidance to streamline manufacturing and testing strategies in Phase I through III clinical programs while ensuring that the clinical trial material (CTM) meets regulatory requirements. InSymbiosis also has the capability of authoring both non-clinical safety as well as CMC sections of regulatory filings. InSymbiosis works in collaboration with a network of regulatory consultants who are able to prepare and submit regulatory filings on behalf of our clients.

• Document management

  InSymbiosis maintains an electronic document and records management system as part of its Quality Management System (QMS). This electronic records management system incorporates a document structure for non-clinical and CMC documentation that follows the CTD structure allowing for easy transfer of information into regulatory filings. In addition, our electronic records management system functions as an electronic Trial Master File (eTMF) to maintain clinical trial documentation. Our electronic records management system is used to maintain documentation for programs that we manage, but can also be used as a stand-alone system to house documentation as a service for our clients.

• Clinical studies

  InSymbiosis offers a very unique service for clinical trials. The uniqueness stems from our vCRO business model that combines InSymbiosis expertise in clinical trial planning and management together with a range of world class clinical CRO partners within our network. The result is InSymbiosis’ ablity to support our client’s clinical needs from the planning stage, though regulatory strategy to trial execution.

  We are able to conduct Phase I – IIa trials in practically all therapeutic areas in both healthy volunteers and special populations as well as Phase IIb and III trials in a large range of therapeutic areas. Further, the trials can be centered on Canadian investigator sites or global, multinational trials. The services we provide through our partnership with leading CROs covers the full range of clinical services including project management, study monitoring, biostatistics, data management, patient recruitment, central laboratory, global safety and pharmacovigilance. The bioanalysis expertise brought to the table by our team and our CRO network provides support to all of our client’s clinical bioanalytical needs. In addition, we are able to support the custom development of diagnostic assays and biomarker assays to complement our client’s complex clinical trial designs.

  Given the importance of clinical studies in the drug development process, the selection of the right CRO partner is paramount. Further, clinical studies are typically the most costly part of a drug development program making the selection of a CRO also a key budgetary decision. What InSymbiosis provides is a truly different way to outsource your clinical studies through our vCRO model that allows selection from a range of qualified and experienced CRO partners together with leveraging our financial tools to drive budget reductions.