Newsletter | November 3, 2022

11.03.22 -- FDA Releases Final Guidance On RWD/RWE Submissions


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
Walmart’s Healthcare Research Institute Is Ready To Aid Underserved Communities

On October 10, 2022, Walmart announced its Healthcare Research Institute (WHRI), with the mission to improve care for underserved communities. WHRI offers the opportunity for patients in rural and underserved communities to participate in clinical research.

Understanding The Art And Science Of CRO Selection

This e-book examines the rationale behind how CROs are selected, why they are retained, and why sponsors opt for one provider or outsourcing model versus another.

The Evolving Trial Sourcing Strategies Of Full Service Versus Functional
The functional service provider (FSP) model has experienced an accelerated adoption and increase in popularity in recent years, due, in part, to the flexibility and control it affords sponsors when compared to full-service offerings (FSOs).
How CROs Can Simplify Billing

Explore how embracing a robust, modern industry-specific ERP solution can help streamline workflows, reduce errors, improve visibility, and enhance your customer’s billing experience.

12 Ways To Avoid Delays In Hemato-Oncology Trials

The COVID-19 pandemic has exacerbated the usual factors that can impact the start of clinical trials, including the need for the right study design, patient recruitment, appropriate inclusion/exclusion criteria, commercial/risk concerns, and compliance with international regulatory constraints. 

Patient Over Process: The inSeption Group Difference

Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.

Regulatory & Compliance
FDA Releases Final Guidance On RWD/RWE Submissions For Drugs And Biologics

The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

What Does The “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.

The Role Of Real-World Evidence To Support FDA And TGA Registrations

Real-world evidence (RWE) can contribute valuable information to new medicine registrations, in particular for diseases that are difficult to assess in randomized clinical trials (RCTs) and for emerging technologies.

Asia Pacific As A Clinical Trials Powerhouse
During the period from 2012 - 2021, APAC became a hotspot for clinical trials, with trial activity trending upward and eventually contributing almost half of the entire global clinical trial activity in 2021. Explore the driving forces and unique differentiators among each location within this region.
The Composition And Value Of A Portfolio Analysis

One of Premier Consulting’s differentiating offerings is the portfolio analysis: a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio.