10.27.22 -- How Important Is CRO Expertise For APAC Trials?

The Asian-Pacific (APAC) region is one of the fastest growing areas for clinical trials. There are many benefits to conducting trials in the region, including low cost, ease of regulatory compliance, a growing patient population, and the presence of top clinical institutions. The APAC CRO market was valued at $7.6 billion in 2021 and is forecasted to reach $12 billion by 2025.

Sponsors primarily outsource to CROs to control operational and infrastructure costs, allowing them to concentrate on what they do best. However, with outsourcing, processes and systems are often duplicated or disparate. Learn why a unified eClinical ecosystem is needed for “trusted collaboration.”

A CRO customer and a clinical sponsor both lacked an unblinded supply management role to oversee interactive response technologies (IRT) platform supply strategies and monitor clinical supply inventory levels.

In September 2021, the FDA issued a notification to the biopharmaceutical industry alerting them that multiple clinical studies conducted by two India-based CROs were “not acceptable” because of data integrity concerns. How can sponsors avoid such situations when selecting and partnering with CROs?

Predicted to expand 5.8% annually through 2030, learn more about how the biopharmaceutical pipeline has nearly 400 therapeutics and vaccines in development.

PCI's team of qualified persons assumes responsibility for all stages of the process, safeguarding patients and including the audit of the supply chain for GMP compliance in addition to certification of products for use in clinical trials.

When you engage with Sikich to implement NetSuite and SuiteSuccess for CROs, you can rely on the industry and technical experience of a successful consultancy with many loyal, satisfied clients. 

First launched in February 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.

Given the right expertise, Rx-to-OTC conversions are easier to achieve with less time and expense than one might expect for a regulatory exercise.

Patients can be assured that their prescribed medicine has been vetted for safety and efficacy by a long and arduous discovery process guided by governmental regulatory agencies. The European Union (EU) recorded a concerning 25% decrease in clinical trial applications (CTAs) from 2007 to 2011, and this downward trend has continued. Find out why.

Manufacturers with aging facilities and technologies are certainly in danger of being found by inspectors to not meet the requirement to remain “current” under cGMPs.

Our advisory workshops enable sponsor teams to prepare for CTIS and beyond, ensuring that they implement best practices. Workshop topics include high-level trends and hands-on plain language summaries, data anonymization and redaction, and transparency policies and SOPs.

Maximize compliance, increase revenue potential, and improve patient safety by leveraging proven technology.