Clinical Research Solutions
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
Clinical Research Solutions
How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration
A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...
Clinical Research Solutions
Recognizing the Value of Outsourcing GxP Audits
In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices, and other regulatory requirements is paramount. Failure to meet these...
Clinical Research Solutions
How to Avoid Blind-Spots in Your Early-Stage Drug Development Program
Navigating the landscape of vital drug development? Discover the five crucial areas that could make or break your success. Early-stage drug development encompasses the initial phases of researching,...
Clinical Research Solutions
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
Clinical Research Solutions
Top 10 Best Practices for Successfully Obtaining Second Round of Funding for Biotech Startups
Securing funding is a crucial milestone for biotech startups aiming to advance their research and bring innovative products to market. Once the initial round of funding is secured, the next challenge...
Clinical Research Solutions
Biotech Start Up: How to Transition from Early Phase Biotech to Late-Stage Biotech
Biotech startups face a number of challenges as they progress through the various stages of drug development. While early-stage biotechs focus on developing and testing their products, late-stage...
Clinical Research Solutions
Compliance Auditing: A Peek into Common Critical Findings
Compliance auditing is a crucial process in the pharmaceutical industry, that helps ensure the safety, effectiveness, and high quality of pharmaceutical products and medical devices. Compliance...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 2
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
Clinical Research Solutions
What You Need to Know About GxP Independent Compliance Audits, Part 1
In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits. the role that independent auditors play in conducting compliance...