Newsletter | October 27, 2022

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


Welcome to the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & ComplianceUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Outsourcing Models
Is CRO Expertise A Factor For Companies Conducting Trials In APAC?

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.

Trusted Collaboration For A Unified eClinical Ecosystem

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.”

Overcoming Inventory Challenges For A Complex, Global Study

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.

Five Things To Remember When Selecting A CRO Partner

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?

FSP Outsourcing Trends: How Sponsors Can Meet Staffing Demands

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

An Introductory Guide To Clinical EU Qualified Person (QP) Services

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.

7 Reasons CROs Should Work With Sikich And SuiteSuccess

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. 

Regulatory & Compliance
FDA’s RTOR Program: Draft Guidance And Insights

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.

Real-World And Late-Phase: Making The Switch From Rx To OTC

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.

EU To Attract More Clinical Trials With Streamlined Submission Process

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.

What Does “Current” In Current Good Manufacturing Processes Mean?

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.

TrialScope Disclosure Services Workshops

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.

Balancing Compliance In Pharmaceutical Data Privacy Regulations

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