Home ▶ Blog ▶ Blog

Blog

Navigating FDA Regulatory Processes as the Government Reopens

November 2025

With the passage of a new spending bill, federal agencies — including the U.S. Food and Drug Administration (FDA) — are resuming normal operations after the October – November 2025 shutdown. While critical FDA review work continued under carryover user fees, the freeze on new submissions and limited communications created operational gaps.

Understanding and Applying EU CTR: Navigating Successful Clinical Trial Submissions

November 2025

For biotech and pharmaceutical companies, especially those with no previous experience with the EU/EEA region, understanding this framework is essential to ensure smooth and regulatory compliant clinical trial submissions.

Regulatory Challenges for Chinese Biotech Expanding Trials to Europe

November 2025

To help guide sponsors through this process, our eight-part blog series, “Regulatory Challenges for Chinese Biotech Expanding Trials to Europe”, breaks down the most critical regulatory topics that impact clinical trial success under the EU CTR framework.

Emerging Immunotherapy Combinations and Novel Approaches for Oncology and Hematology: Keys to Designing and Operationalizing Your Trial

October 2025

The past decade has seen immunotherapy shift from a promising innovation to a core pillar of cancer treatment. What began with checkpoint inhibitors has now expanded into a crowded pipeline of biologics, antibody-drug conjugates, cell therapies, and precision medicine strategies.

World Mental Health Day 2025: The People Behind Clinical Research

October 2025

In clinical research, much of our focus centers on timelines, milestones, and deliverables, the measurable outcomes that define project success. But behind every protocol, every database lock, and every submission deadline is a person.

Recognizing Breast Cancer Symptoms: Clinical Considerations Across Oncology and Women’s Health

October 2025

Breast cancer is the most commonly diagnosed cancer in women globally, with more than 2.3 million new cases each year. While significant progress has been made in diagnosis and treatment, early detection remains one of the most powerful tools for improving patient outcomes.

Dermatology Imaging and Innovation: Raising the Quality Bar

October 2025

The session brought together industry experts to discuss the latest advances in dermatology clinical trial imaging, including the integration of photography and artificial intelligence (AI).

Navigating FDA Regulatory Challenges During a U.S. Government Shutdown

October 2025

As of October 1, 2025, the U.S. government has entered a partial shutdown because Congress failed to pass the appropriation bills required for fiscal year 2026.

Protecting Pediatric Patients: Advancing Drug Safety Through Pharmacovigilance

September 2025

In drug development and clinical practice, children are often misunderstood as merely requiring a scaled‑down version of adult doses.

Requesting FDA feedback early in development (in addition to Pre-IND Meeting)

September 2025

If you're in the early stages of product development and wondering what the FDA might think about your approach or if your product doesn’t fit neatly into existing categories, this meeting could give you clarity, confidence, and a stronger path forward.

Considerations in conducting Rare Disease studies: Lessons from our Boston Seminar

August 2025

During a recent dinner seminar in Boston, we shared deeply personal, practical, and strategic insights on what it truly takes to operationalize rare disease clinical trials. The event was filled with candid observations, compelling stories, and bold challenges to conventional thinking.

ASCO 2025: Key Takeaways for Clinical-Stage Biopharma Innovators

June 2025

At the 2025 ASCO Annual Meeting, key trends emerged in immunotherapy, antibody-drug conjugates, precision medicine, and clinical trial design.

The Caidya Values Recognition Awards 2025

June 2025

To honor our dedicated teams and individual team members, we recently held the Caidya Values Recognition Awards 2025. We invite you to learn about our teams and people who go above and beyond to exemplify our core values as they help our clients bring life-changing products to patients.

Our Culture of Caring: Demonstrating our Commitment to the Communities We Serve

May 2025

At Caidya, our commitment to patient-focused research extends into the communities we serve. Project Manager Natalie Negron recently participated in Lauren’s Run & Picnic, a community event supporting pediatric cancer research, and shared how experiences like this bring deeper meaning to our mission.

Boost Your Dermatology Studies: 5 Operational Essentials

April 2025

Dermatology studies demand careful planning and precise execution to ensure the reliability and validity of research outcomes.

Creating Your Blueprint: Strategic Planning for Early Phase Clinical Trials

March 2025

As the first stage of testing a new treatment in humans, the results from an early phase clinical trial provide critical data about safety and efficacy and help inform decision-making.

Strategies for Dose Selection in Oncology Drug Development: Optimus Project and Beyond

March 2025

In the world of cancer drug development, finding the right dose is a crucial step that can make a significant difference in how well a treatment works for patients.

Leading a new way

The latest from Caidya

Explore our news and updates as we deliver a superior customer experience.

News

11/20/2025

Caidya Reimagines Next Generation Clinical Trial Innovation and Study Delivery with Medidata AI-Powered Experiences

New Experiences solutions, including Medidata CTMS and Medidata Clinical Data...

Read more

News

09/19/2025

Caidya Appoints Dr. Bin Peng as Chair of its China Scientific Advisory Board

RALEIGH, N.C.; September 19, 2025 – Caidya, a leading global...

Read more

News

07/21/2025

Caidya’s John Wang Named Chair of China CDISC Coordinating Committee; Medidata Accreditation Underscores Data Management Excellence

RALEIGH, N.C.; July 22, 2025 – Caidya a global, technology-enabled clinical...

Read more