Market Research Report
Early-Stage Product Development
|Published by||Cutting Edge Information||Product code||486148|
|Published||Content info||115 Pages
Delivery time: 1-2 business days
|Early-Stage Product Development|
|Published: February 28, 2017||Content info: 115 Pages||
As life sciences industry groups work to improve patients' quality of life, preclinical development presents a pivotal step. Multiple preclinical subgroups usher emerging products to the clinical stage. These groups' expertise provides a joint technology, medical, physics and engineering backbone for companies' initial research and development (R&D) operations.
Specific groups involved in preclinical work include toxicology, pharmacology and material biocompatibility. Other core teams that may support preclinical operations include quality assurance and information technology (IT) groups. Together, these groups collect invaluable information - from safety data to pharmacokinetic and pharmacodynamic insights - necessary to propel products from preclinical research to formal clinical studies.
From the R&D perspective, life science teams may have different pathways to improve existing medical treatment options. Pharma groups may formulate active ingredients which require extensive preclinical and clinical testing.
On the other hand, medical device companies may develop diagnostic tools and drug delivery systems. Medical device trials can be comparatively short - requiring between three and four months. They could also require fewer patients; compared with thousands of patients enrolled in pharma and biotech companies' Phase 3 studies, device trials may require at most 200 to 300 patients. Medical device company teams do not necessarily have formal Phase 3 studies. But these teams typically perform additional testing to validate safety and ensure that proposed treatments surpass existing standards of care.
This report's benchmarks address the preclinical landscape with a look at applicable regulations, team structures, staffing and budgetary resources and activity types. Among its many insights, this report also provides a look at the types of preclinical tests that dedicated teams perform. Surveyed preclinical groups may undertake different activities; this report explores the myriad resources to sustain these activities.