Hi there — here are a few resources you can skim quickly and share with your team.

Best Practices for Building Strong Regulatory Relationships in Small Biotech Companies

Small biotech companies that engage early, prepare thoroughly, and partner with experienced CROs are better positioned to build trust with global regulators and accelerate development timelines. Avoiding common pitfalls—such as withholding information or presenting conflicting internal messaging—is just as important as proactive engagement. The right strategic partnerships can turn regulatory complexity into a competitive advantage.

Building a More Robust Biomanufacturing Network

When a new bioreactor created an unsustainable buffer preparation burden, Biogen outsourced the process to Thermo Fisher Scientific, eliminating 250 FTE hours per batch and reducing internal preparations from 23 to just 1.25 per batch. The increase in material costs was outweighed by labor savings and workforce reallocation to higher-value activities, demonstrating the clear operational and financial case for strategic buffer outsourcing.

How One Large Pharma's Global Phase I Trial Slashed Biospecimen Queries by Up to 80% With Slope

In a head-to-head comparison within a single global Phase I trial, sites using Slope's biospecimen lifecycle management platform achieved 78% fewer urgent queries, 80.5% fewer total queries per subject, and zero missing sample events compared to sites using standard procedures. These results were delivered despite the absence of EDC and lab kit integrations, demonstrating that even a constrained Slope deployment drives significant gains in data quality and operational efficiency.

Success from Day One

The first 120 days of a clinical trial can make or break a program, especially for emerging biotechs with a single investigational asset and lean internal teams. This white paper outlines how a structured CRO partnership — built on early alignment, regulatory preparedness, and transparent communication — creates the operational foundation needed for clinical success. Getting these fundamentals right from day one dramatically improves a sponsor's ability to stay on track when inevitable challenges arise.