We partner with CROs, CDMOs, SMOs, E-Clinical, technology, specialty and full service providers to fill a range of positions from Associates to C-Level.
Drug Discovery is the initial stage (non-GLP) in the drug R&D process that aims to understand the nature and causes of a disease through identifying proteins known as “targets”, associated with the disease that are critical to the survival or spread of the disease-causing organism. Through analyzing, testing, and re-testing tens of thousands of drug compounds, scientists and researchers seek to narrow these compounds to a select few that positively affect the disease target, often called “hits”, that will eventually lead to these compounds becoming drug candidates.
Pre-Clinical is the 2nd stage in the drug development process, in which up to 250 drugs that passed through the Discovery stage are tested in-vitro (test tube) and then in-vivo (animal studies), adhering to Good Laboratory Practice (GLP) guidelines. The goal is to identify up to 5 of the tested drugs that will be safe and effective enough to be submitted to the FDA through an Investigation New Drug (IND) application for approval before advancing to clinical, human trials.
Once a drug’s IND application has been approved, clinical trials begin on humans. The drug is tested on increasing numbers of human patients over 3 phases (I, II, and III) of clinical trials following Good Clinical Practice (GCP) guidelines. Generally-speaking, only 1 drug will survive the trials, be found safe and effective, and is submitted to the FDA through a New Drug Application (NDA) before it can be approved for market and commercialization (Phase IV).
Phase I is the initial phase of clinical trials, often known as “first-in-man” studies, and is focused primarily on the drug’s safety, as it is tested on a group of approximately 20-100 generally healthy human patients using pharmacovigilance methods. Single-ascending dose studies are first administered (Phase Ia) to small groups of patients before increasing to multiple-ascending dose studies (Phase Ib) new groups of patients.
Phase II is primarily focused on dosing studies (Phase IIa) and effectiveness studies (Phase IIb) of the drug, although safety continues to be monitored, and is generally administered and tested on approximately 100-500 patients affected by the disease or condition being targeted.
Phase III trials involve a much larger and diverse group of affected patients, with approximately 1000-5000 receiving the drug (Phase IIIa), is the longest and costliest, is key in determining the drug’s safety and effectiveness, and provides the basis for labeling instructions (Phase IIIb). Upon successful completion of Phase III, a New Drug Application (NDA) is filed with the FDA and, if approved, can then be brought to market with ongoing surveillance and analysis (Phase IV).
Phase IV trials take place after the FDA approves the drug’s marketing and commercialization. Here, trials are conducted to identify and evaluate the drug’s long-term effects for larger number of patients, which allows the new drug to yield more information about its efficacy, safety, and side effects.
Adaptive Design Studies
Cardiac Safety ECG Monitoring
Clinical Data Management
Functional Service Providers
Late Clinical Trials
Safety & Pharmacovigilance
Manufacturing of drugs and their packaging begins in Pre-Clinical on a small-scale, is ramped up to a large-scale throughout the Clinical stage, and is a different process from drug to drug. Each manufacturing facility must meet strict FDA guidelines for Good Manufacturing Practices (GMP), which is the part of quality assurance that ensure products are produced and controlled to the highest standards in facilities, equipment, and methods.
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C-Level, Vice, President, Director, Associate