Non-Clinical
Program Design
Non-clinical pharmacology and toxicology programs must be designed to support
the intended route of administration and duration of dosing sought for the
investigational drug. In addition, most programs require the development of
the appropriate bioanalytics to support the toxicokinetic and pharmacokinetic
components of the non-clinical program. SWG helps clients design the non-clinical
program and support assays in accordance with FDA- and ICH-recommended
guidelines.
CRO Assessment and Oversight
Swiftwater Group can help identify appropriate CROs to
conduct non-clinical studies, including GLP and QA inspections
(see "Quality Assurance"). Once studies are placed, SWG can continue to act
as a liaison with the CRO to ensure protocol compliance and timely completion
of studies.
Non-Clinical Study Management
Depending on the compound (e.g., NCE, reformulated
generic, follow-on biologic), the length of the non-clinical program will vary
from months to several years. This process requires continued management of
the program to ensure careful management of research material supply, timely
execution of the studies, prompt generation of the reports, and appropriate
updating of supporting documents (e.g., IB, IND). SWG consultants are experienced in the management of the most
detailed of non-clinical programs and can provide clients the resources needed
to ensure the studies are done on time and as planned.
Non-Clinical Summary Preparation for
Regulatory
Review
After completing the non-clinical studies and auditing the study reports, all
GLP studies need to be summarized for regulatory review documents. SWG can
prepare or facilitate the preparation of these summary documents for inclusion
into INDs, IBs, CTAs, CTDs and NDAs.
