Quality, reliable data is the key to successful drug development. From the initial preclinical data, the plan to bring a drug to market is built upon the foundation of solid, reliable data that demonstrates safety in a human patient population.

In this journal, we lead you on the complex, multi-step data journey for Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

In Issue 29 of The Altascientist we explore: 

• Protocol development
• Data management
• Statistical support
• Analysis and reporting

Liquid-filled hard-shell capsules (LFHCs) are a popular formulation for oral solid delivery of chemical drugs and nutraceuticals. Often selected for drugs with poor solubility/bioavailability, LFHCs also have applications in a number of other situations, including specific benefits during early-phase clinical development.

In Issue 28 of The Altascientist, you will find: 

• Applications of LFHCs
• The production process
• The role of excipients
• Other advantages of LFHCs A case study
• How Altasciences can help

Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.

In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including: 

• Prototype development, formulation, and manufacturing
• Preparing for first-in-human studies
• Species and strain selection parameters
• Routes of administration
• Specialized ocular assessments and equipment
• bioanalysis
• Phase I clinical research
• Phase II to commercialization

Three case studies are also included!

The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.

In Issue 26 of The Altascientist: 

• Introduction to standardization and its benefits
• Client considerations for nonclinical and clinical data standardization Case Study — Realized Efficiency
• Case Study — Realized Efficiency
• Case Studies — Legacy Data Conversion
• The future of CDISC and data strategy