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How Pharmacogenomics Can Benefit Your Clinical Trial

Conversations in Drug Development Trends

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

These treatments use a vector to introduce the desired nucleic acid code to replace or modify protein expression or use cells to alter/restore a specific cell type. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.

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Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs

PPD

Food and Drug Administration defines these groups as: Neonates: newborns up to 1 month Infants: 1 month–2 years Children: 2–12 years Adolescents: 12–16 years Pediatric clinical trials must account for different age groups and developmental stages, as children’s physiology and response to treatments can vary significantly.

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Keeping tabs on Covid-19: Starpharma creates slow release remdesivir nanoparticl…

The Pharma Data

While stories from news outlets indicate the peak of the infection has passed in most European countries, cases of the disease continue to rise in other parts of the world, especially Latin America and Africa. Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease.

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Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Conversations in Drug Development Trends

From their use in risk and safety assessments to patient screening and treatment efficacy, biomarkers offer minimally invasive, objective data. For a more in-depth look at biomarkers, check out our white paper. Deviations from established baseline values provide insights into treatment response in certain cancer indications.

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Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Conversations in Drug Development Trends

Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. Umbrella Studies Umbrella studies evaluate multiple investigational products (IPs) within a single disease. But how do they work, and when are they appropriate? What Are Master Protocols? Contact us.

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Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Agency IQ

Given the widespread use of CDISC for clinical research and HL7 for electronic health record (EHR) data, the two organizations have partnered to create mapping guides to streamline the flow of data from EHRs to CDISC submission-ready datasets, and vice versa. CMS in the United States ).

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