Evolution of Clinical Trials: Address the Challenges of the Future

The first modern randomized controlled trial took place in 1948 testing streptomycin for pulmonary tuberculosis. Since then, clinical research trials have significantly evolved in terms of their impact on regulation and scientific and statistical foundation. Important developments over the last decade came with the Clinical Trials Transformation Initiative (CTTI). The CTTI addressed and proposed solutions for a range of operational and scientific trial-related issues.

GMP Compliance: What Is the Challenge?

Beyond regulatory compliance, good manufacturing practice (GMP) compliance is a necessity for pharmaceutical manufacturers. GMP compliance guidelines ensure high-quality standards for manufacturing and control above and beyond the regulatory requirements of safety, quality, and efficacy. All top pharmaceutical manufacturers are encouraged to become GMP certified.

Contract Research Organization Growth and Investment

Many Contract Research Organizations (CROs) are consolidating to offer key discovery, early stage efficiencies, and expert clinical stage trial services in the lab to speed up drug development.

Over the past decade or more, the industry has searched for better ways to manage the costs and risks of drug development for commercial performance and therapeutic efficacy long after approval.