Assay development is critical in identification and confirmation of "hits", lead optimization and generating drug candidates for development. GenScript offers a comprehensive functional in vitro assay platform, using fluorometry, radioactivity, electrophysiology and cell-based assays. We are equipped to perform high throughput screening of compound libraries and can customize primary assays, secondary assays and specificity assays for your drug development needs.

Our scientists are experts in the development and application of cell based assays for drug discovery projects and similar research. In addition to standard cell survival and proliferation assays, we can carry out various receipts/enzyme induction/inhibition assays

One of the limitations of preclinical efficacy evaluation is the lack of appropriate animal models covering important aspects of the human disease. On the other hand, humanization of drugable targets offers a valuable tool for the preclinical evaluation of human therapeutics and especially of biologics.

Through partnerships, DiscoverSys offers both large and small animal model studies to the Pharmaceutical industries. Our clients' studies are placed only at reputable CROs / academic labs that specialize in the animal model required for the specific application of the product candidate. Sample testing is completed in laboratories with appropriate expertise, again matched to product development requirements. Intimate involvement in the protocol preparation and sample retrieval process ensures that our clients' product candidates are tested appropriately

A standard operating procedure (SOP) is a document with detailed instructions and methodology to be followed, in order to maintain uniformity and consistency in results. The International Conference of Harmonization (ICH) defines SOP as, “detailed written instructions to achieve uniformity of the performance of a specific function.

It is the responsibility of everyone (be it pharmaceutical company, contract research organization (CRO), sponsor, investigator, or any other party) involved in the process of drug development to prepare and follow a good SOP, in order to attain highest level of safety and efficacy of performed clinical trial. Regulatory Authority should make it mandatory for all the parties involved or conducting Clinical Research and Clinical Trials to get their SOPs verified before getting a license to perform their operations or trials. Apart from this, every employee in the organization should be well trained to follow these SOPs. An organization following a standard procedure obviously has a competitive edge over those who are not following the standard operating procedure, SOP.

Pharmacokinetic / pharmacodynamics (PK/PD) modeling, an integral component of the drug development process, is a mathematical technique for predicting the effect and efficacy of drug dosing over time. Broadly speaking, pharmacokinetic models describe how the body reacts to a drug in terms of absorption, distribution, metabolism, and excretion. Pharmacodynamic models describe how a drug affects the body by linking the drug concentration to an efficacy (or safety) metric. A well-characterized PK/PD model is an important tool in guiding the design of future experiments and trials.

DiscoverSys team has expertise in the application and presentation of pharmacokinetic (PK) and pharmacodynamic (PD) principles for successful drug approval

Engaging early with experienced statisticians in support of your research, development and operational activities can bring benefits to you and your organisation that extend go beyond the generation of p-values and basic analyses. These benefits include more efficient experimental and novel trial designs, more effective data analyses and better use of data and a positive impact on your overall strategy and critical decision making.

Our statistical consultants possess decades of experience of delivering statistical advice to a wide diversity of drug discovery projects. Our team offers advice on the execution of statistical analysis; how to plan your study including what sample size you should use, protocols to follow and how to analyse your data. We can also assist with independent statistical reviews including reports, project proposal assessments, methodological review and evaluation of research methodology.