Credevo Articles |

Mar15 0

Preparing for Post-Patent Generic Launch Credevo

When patents for Reference Listed Drugs (RLDs) expire, it opens the door for generic manufacturers to offer more affordable alternatives to brand-name drugs. However, successful entry into the market requires careful preparation ahead of the patent expiration. To demonstrate that a generic drug is equivalent to its branded counterpart, companies conduct thorough clinical research. This […]

Mar05 0

The pharmaceutical industry is undergoing a major change as patent exclusivity expires for popular drugs, highlighting vast generic drug opportunities. This shift will open up a $236 billion opportunity for generic and biosimilar manufacturers between 2025 and 2030. This significant loss of patent protection means more than just the end of exclusive rights. It will […]

Feb25 0

Choosing the right country for a clinical trial, particularly in complex therapeutic diseases, is a difficult task due to its reliance on factors that databases and standard metrics cannot fully measure. When therapies involve advanced technologies like modified immune cells or genetic interventions, the analysis must extend beyond basic feasibility. It requires examining site capabilities […]

Feb15 0

Shipping Tracking Devices for Use In Clinical Trials in Japan

Digital tracking devices play a pivotal role in modern clinical trials. They enable remote monitoring, enhance patient safety, and support continuous, real-time data capture. However, navigating Japan’s regulatory requirements for importing these devices can be complex and device-specific. Japan welcomes these advanced technologies, which are reshaping the design and execution of clinical trials. Therefore, it […]

Feb05 0

How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Japan has one of the most tightly regulated pharmaceutical landscapes, which necessitates a seamless supply of laboratory kits (for clinical trials) to its sites. The process requires strict adherence to the guidelines of the Pharmaceuticals and Medical Devices Agency (PMDA). For sponsors and CROs, this raises the question of how to supply laboratory kits to […]

Jan25 0

Shipping Clinical Trial Materials to Japan through IOR/EOR

Shipping clinical trial materials, such as ancillaries, medical devices, or Investigational Medicinal Products (IMPs), to Japan requires a thorough understanding of the laws and local regulatory systems. Understanding the challenges for shipping clinical trial materials to Japan begins with recognizing how the country’s regulatory framework differs from most others. Japan’s clinical trial regulations differ from […]

Jan15 0

Clinical trials on traditional medicines

The Asia-Pacific region is home to a diverse array of traditional medicinal practices. The region is also rich in a large and diverse population. This diversity includes genetic variations, dietary patterns, environmental factors, and disease profiles, which makes trial results more applicable across global populations. Moreover, the growth of research facilities presents opportunities for sponsors […]

Jan05 0

Image showing India as a growing hub for nutraceutical clinical trials.

India is emerging rapidly as a global research and development hub for nutraceuticals. The country conducts nutraceutical clinical trials at lower costs while ensuring that the quality meets international standards. Nutraceutical clinical studies in India follow a regulated pathway, requiring approvals from both an Ethics Committee and the Central Drugs Standard Control Organization (CDSCO). It […]

Dec25 0

Effective cost management serves as a way to overcome budget challenges in clinical trials. A proper understanding of the key cost factors that emerge throughout the study lifecycle helps to mitigate such challenges. Factors such as patient recruitment, regulatory compliance, site management, and data collection each contribute significantly to the total expenditure. When the cost […]

Dec15 0

Image depicting managing protocol deviations in visual function assessments in opthalmology clinical trials

Protocol deviations for Visual Function Assessments (VFAs) in ophthalmology trials can affect the accuracy and reliability of outcomes. A VFA measures an individual’s functional or practical visual capabilities. This is in contrast to a standard eye exam, which includes a series of tests to measure real-world visual skills. VFAs perform both quantitative and qualitative assessments […]

Preparing for Post-Patent Generic Launch: A Practical Guide to Bioequivalence Studies

Trending Molecules and Generic Drug Opportunities: Blockbuster Drugs With Upcoming Patent Expirations (2026–2030)

Choosing the Right Country for Your Clinical Trials in Complex Therapeutic Diseases: Why Investigator and Site Perspectives Count?

Shipping Tracking Devices for Use In Clinical Trials in Japan: Everything You Need to Know

How to Supply Laboratory Kits to Clinical Trial Sites in Japan: A Step-by-Step Guide for Sponsors and CROs

Top 5 Challenges for Shipping Clinical Trial Materials to Japan: How Sponsors and CROs Can Overcome Them

Conducting Clinical Trials on Traditional Medicine in the Asia-Pacific Region: Opportunities and Advantages

Nutraceutical Clinical Trials: India as a Growing Hub

Navigating Budget Challenges in Clinical Trials: Practical Strategies for Cost Management

Ophthalmology Trials: Managing Protocol Deviations in Visual Function Assessments