Newsletter | July 18, 2024

07.18.24 -- 'Real' Evidence Generating Real Pre- And Post-Market Benefits

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Right-sized for biotech success

It’s not the size of your company. It’s the size of your passion and your dedication to improving patients’ lives that IQVIA Biotech is uniquely built to serve. There is nothing bigger to us than your success. We’ve got you.

REGULATORY & COMPLIANCE

'Real' Evidence Generating Real Pre- And Post-Market Benefits

Review current and future applications of RWD/E in drug discovery, clinical research, regulatory approval, and its role in promoting health equity and patient access.

The Future Of Regulatory Operations

The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

CAPA Framework: Realizing Business Benefit, Inspection Readiness

Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.

What Do Biostatisticians Think Of The ICH E9(R1) Addendum?

Gain insights from Kristina Bondareva, Head of Biostatistics at OCT Clinical, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.

Clinical Quality Assurance And Compliance Oversight

Explore this tailored assessment and support offerings in clinical quality assurance (CQA) compliance, designed to safeguard adherence to relevant regulations and good clinical practice (GCP).

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Explore the forefront of precision medicine at the Advancing Precision Medicine Conference and Exhibition in Philadelphia, November 1-2. Engage with cutting-edge research featuring experts who are shaping the future of healthcare. Discover new insights into personalized treatments, genomic advancements, and innovative technologies revolutionizing patient care. Expand your knowledge and network with leaders driving the field forward. View the agenda and register today!

OUTSOURCING MODELS

5 Years Of CRO Leadership Awards

Are the same companies winning the CRO Leadership Awards year over year? I decided to look back at the data to find out.

Can Optimized Cardiology Trials Solve Major Challenges?

Great science doesn’t save lives simply by existing. To make sure it’s properly implemented, it’s vital that a complete and functional process is in place.

Uncovering Hidden CRO Contract Costs Before Signing A Contract

Navigating the complex landscape of clinical trials can be challenging. Utilize this reliable CRO Checklist to empower teams to stay ahead and safeguard every trial's budget effectively.

Outsourcing Lifecycle Maintenance To A FSP Regulatory Affairs Partner

Drug developers face numerous regulatory requirements when bringing new drugs or devices to market. An FSP partnership can streamline your regulatory processes, ensuring sustained compliance and efficiency.

CNS Drug Development: Integrated Solutions To Reduce Complexity

Understand how early engagement with a fully integrated and experienced CNS drug development partner can accelerate timelines by facilitating continuous data sharing and decision-making.

Advancing Your API To First Human Dose Trials More Efficiently

See how end-to-end support for development and manufacturing, clinical trial services, advanced drug delivery, and commercial packaging can accelerate drug development and time to market.

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Patient recruitment and retention is a multi-faceted, critical component of clinical trial success. Diversity, timeliness, enrollment, reimbursement, logistics, engagement – where do you start? On August 7th, hear from industry-leading suppliers ready to answer that question – and help solve your specific recruitment and retention challenges. The Clinical Leader Solutions Expo brings you its latest virtual event to help facilitate partnerships that bring life-saving therapies to patients. Register, ask questions, and find your best-fit solution for free.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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