Phase 1 - BioPharma Services

Computerized Assessments of Cognitive and Subjective Drug Effects Used in Clinical Trials

by The BioPharma Team | May 9, 2023 | All Blogs - Clinical Research, Human Abuse Potential, Phase 1, Sponsors

Computerized Assessments of Cognitive and Subjective Drug Effects Used in Clinical Trials Computerized assessments can be used to measure the pharmacodynamic response to a study drug in clinical trials. Pharmacodynamics measure the effects of the drug on the body,...

How Decentralized Trials are Changing the Clinical Research Landscape

by The BioPharma Team | May 2, 2023 | All Blogs - Clinical Research, Phase 1, Sponsors

How Decentralized Trials are Changing the Clinical Research Landscape Clinical trials play a crucial role in the development of new drugs and treatments, but traditional human clinical trials have limitations that can impact the validity and generalizability of the...

Cannabis Research: New Opportunities Open for Non-Therapeutic Studies

by The BioPharma Team | Apr 26, 2023 | All Blogs - Clinical Research, Phase 1, Sponsors

Cannabis Research: New Opportunities Open for Non-Therapeutic Studies Health Canada has recently updated regulations, lifting restrictions on cannabis research for non-therapeutic purposes. This change allows researchers and licensed dealers to investigate and develop...

Clinical Drug Development and European Sponsors

by The BioPharma Team | Apr 26, 2023 | All Blogs - Clinical Research, Bioanalysis, Bioequivalence, Human Abuse Potential, Phase 1, Sponsors

Clinical Drug Development and European Sponsors Efforts to Harmonize Regulatory Requirements The drug development process is constantly evolving and incorporating advances in scientific research, including progress in personalized medicine and big data use. However,...

Drug Development and Alternative Routes of Administration

by The BioPharma Team | Apr 17, 2023 | All Blogs - Clinical Research, Phase 1, Sponsors

Drug Development and Alternative Routes of Administration Approved drugs can be administered via many routes of administration, including oral, intravenous, intramuscular, subcutaneous, sublingual, topical, intranasal, intraperitoneal, intrathecal, rectal, vaginal,...

Clinical Study Report Development: Bioequivalence-Generic Products

by The BioPharma Team | Mar 17, 2023 | All Blogs - Clinical Research, Bioequivalence, Phase 1, Sponsors

Clinical Study Report Development: Bioequivalence-Generic Products As a drug development sponsor, you know that creating a Clinical Study Report (CSR) is a critical part of the drug development process. It is a crucial component for regulatory agencies when...

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