Credevo Articles |

Sep05 0

Partnering with Site Networks in Rare Disease Trials

Partnering with site networks offers a strategic solution to overcome the unique challenges of conducting clinical trials in rare diseases. Limited patient populations, complex recruitment pathways, and the geographic dispersion of expertise often hinder the progress of these trials. By leveraging established relationships, specialized knowledge, and streamlined processes, site networks can enhance trial efficiency, accelerate […]

Aug25 0

The integration of Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) is transforming how clinical trials are planned, managed, and executed. By connecting these systems, organizations can eliminate data silos, reduce manual errors, and ensure real-time information flow across trial stakeholders. This integration enhances regulatory compliance, improves trial […]

Aug15 0

Mastering Clinical Operations in AsiaPacific

Clinical operations in the Asia Pacific are rapidly evolving, driven by increasing regulatory harmonization, diverse patient populations across all therapeutic indications, and the adoption of innovative technologies such as decentralized clinical trial platforms, real-time data capture and analysis tools, and AI-powered site selection systems, making the region a strategic hub for current and upcoming global […]

Aug05 0

BA/BE studies 2025 are essential for global generic drug submissions. As the number of submissions continues to increase, countries are actively enhancing their capabilities to keep pace. India has positioned itself as a preferred destination, supported by its technical expertise, growing infrastructure, and regulatory alignment. BA/BE studies are cornerstones in developing and approving generic medicines, […]

Jul25 0

In clinical trials, traditional feasibility is often assessed through a feasibility questionnaire means figuring out if a planned study can run, whether it’s practically possible, ethically sound, and likely to work at the specific site or within the region where it’s proposed. Beyond the feasibility questionnaire, determining if a clinical trial will work is extremely […]

Jul15 0

The Drugs Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO), overseeing DCGI approval in India, regulation, and quality standards of drugs and clinical trials. As the national regulatory authority, DCGI ensures patient safety and compliance with the Drugs and Cosmetics Act, 1940. DCGI in the Indian pharmaceutical and medical device […]

Jul05 0

AI in Electronic Data Capture (EDC) in clinical trials is reshaping how research teams collect, manage, and interpret study data. At its core, EDC is a software system designed to replace paper case report forms (CRFs) by enabling structured, digital data collection for clinical research. It allows investigators and site staff to enter, verify, and […]

Jun25 0

Essential Clinical Trial Tools & Systems for Smarter, Faster Studies

Essential clinical trial tools and systems, such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master File), eConsent, and eCOA (electronic Clinical Outcome Assessment), form the digital backbone of modern research operations. These platforms simplify study planning, documentation, patient engagement, and data collection. They ensure trials are more efficient, compliant, and focused on patients. […]

Jun15 0

BA/BE Study Requirements for FDA Approval

For anyone seeking generic drug approval in the USA, a Bioavailability and Bioequivalence (BA/BE) study is often a critical step. These studies show the FDA that your product works just like the approved brand-name version, meeting strict guidelines for safety and effectiveness. Choosing the right global location for your trial, managing costs, and ensuring the […]

Jun05 0

Clinical Operations In North America: Innovation Vs. Oversight

Clinical operations in North America are changing quickly. New technology and capabilities are appearing with more regulatory oversight, balancing these opposing forces, and clinical operations are experiencing further innovation and transformations. In this article, we examine the full spectrum of clinical operations, highlighting strategic innovations and robust oversight practices that have been adopted across North […]

Partnering With Site Networks In Rare Disease Trials: Why Is It Important For Your Clinical Trials

Modernizing Clinical Trials: The Role of eTMF, CTMS, and EDC Integration

Mastering Clinical Operations In Asia-Pacific: Overcoming Challenges With Smart Solutions

Why India Leads Global BA/BE Studies in 2025: Strategic Advantages for International Submissions

Beyond The Feasibility Questionnaire: Rethinking Feasibility Assessments In Asia-Pacific Trials

DCGI Approval In India: A Complete Guide To Drug Regulations, Clinical Trials, & Patient Safety

The Future Of Data: How AI In Electronic Data Capture (EDC) Is Transforming Clinical Trials

A Guide To Essential Clinical Trial Tools & Systems For Smarter, Faster Studies

BA/BE Study Requirements For FDA Approval: Guidelines, Global Locations, Costs & Quality Standards

Clinical Operations In North America: Innovation Vs. Oversight