Curexbio is a Clinical Research Organization (CRO) that provides comprehensive trial management services to ensure efficiency, compliance, and success across all phases of clinical studies, from early development to post-market surveillance.

What core services does Curexbio offer to support clinical trials?

Curexbio offers a robust suite of services including comprehensive clinical trial management, strategic clinical development, diligent clinical monitoring, and extensive pharmacovigilance, all designed to streamline and enhance the success of your clinical studies.

How does Curexbio ensure patient safety and ethical compliance in clinical trials?

Curexbio prioritizes patient welfare through vigilant pharmacovigilance, strict adherence to ethical guidelines, and rigorous monitoring protocols. We ensure all studies comply with international standards like ICH-GCP, safeguarding participant rights and well-being.

What are the advantages of partnering with Curexbio for clinical research?

Partnering with Curexbio offers numerous advantages, including access to our expertise-driven approach, streamlined trial management for efficiency, assured regulatory compliance, and a client-focused collaboration model designed to achieve successful outcomes and accelerate market approval.

Which phases of clinical studies does Curexbio support?

Curexbio provides comprehensive support across all phases of clinical studies, from early-phase clinical development and initial monitoring through to late-stage trials and crucial post-market pharmacovigilance.

How does Curexbio ensure data quality and integrity in clinical trials?

Curexbio maintains high data quality and integrity through meticulous clinical monitoring, robust data management practices, and strict adherence to regulatory guidelines. Our processes are designed to ensure accuracy, reliability, and security of all collected data.

What is Curexbio's approach to regulatory compliance?

Curexbio integrates regulatory compliance into every aspect of its clinical operations. We stay abreast of evolving global and local regulations, ensuring all studies are conducted and documented in full accordance with the latest scientific and regulatory standards.

Does Curexbio offer customized solutions for specific client needs?

Yes, Curexbio prides itself on a client-focused approach. We work collaboratively with each client to understand their unique needs and challenges, offering customized clinical trial management and development solutions tailored to specific project requirements and therapeutic areas.

Data Management

Our CDM team ensures high-quality, reliable data across all study phases, accelerating drug development by upholding rigorous standards and leveraging deep process expertise.

A Comprehensive Data Management System for End-to-End Clinical Support

CurexBio’s state-of-the-art data management system is engineered to support every single phase of your clinical trial, ensuring unparalleled precision and unwavering compliance at every step. Our extensive services are meticulously crafted to maximize data integrity and facilitate timely, informed decision-making throughout the study lifecycle:

Electronic Data Capture (EDC) System Setup and Management

We are wizard in the immaculate setup, on-going management, and configuration of Electronic Data Capture (EDC) systems. Our team creates user-friendly, secure EDC platforms tailored to your protocol and therapeutic area. This assures effective data collection, decrease transcription inaccuracy, and advances data query generation. Real-time visibility allows proactive monitoring and early identification of trends or issues, enhancing operational efficiency and data quality in clinical trial data capture. These setups notably boost the overall operational efficacy.

Robust Database Design and Development

Our highly skilled experts specialize in designing and developing robust, flexible, and highly scalable clinical databases. Our focus is on creating a logical, efficient data structure that optimizes data entry, streamlines validation processes, and facilitates accurate retrieval. We ensure the highest quality of clinical trial data by adhering to global regulatory compliance standards and industry best practices, such as ICH GCP and 21 CFR Part 11, CDISC standards, to assure synergism and future advantage.

Rigorous Data Validation and Query Management

Our data validation process includes diligent reviews, guaranteeing the integrity e and reliability of clinical trial data. This proactive approach identifies discrepancies, inconsistencies, and protocol deviations in real-time, enabling rapid resolution. Our thorough validation methodology includes edit checks, range checks, and consistency checks, resulting in clean, auditable datasets. The query about lifecycle is managed with precision, ensuring timely resolution and comprehensive documentation.

Comprehensive Data Cleaning and Reconciliation

Clinical trial data undergoes a meticulous cleaning and reconciliation process before statistical analysis. This involves identifying and resolving any anomalies, duplicate entries, or inconsistencies, ensuring a complete and accurate dataset. This process involves reconciling data from various sources, including laboratory data, central labs, and external vendors, ensuring the scientific validity and reliability of the study results, and minimizing potential biases.

Precise Medical Coding (MedDRA & WHODrug)

Our team provides accurate, consistent, and regulatory-compliant medical coding for adverse events, medical histories, and medications using industry-standard terminologies like MedDRA and WHODrug. This is crucial for safety reporting, trend analysis, and ensuring comprehensive regulatory compliance, facilitating effective pharmacovigilance across all jurisdictions.

Secure Data Export and Transfer

We facilitate secure data export and transfer services in industry-standard formats like SAS, CDISC SDTM, and ADaM, ensuring seamless, secure, and compliant transfer of clinical trial data for statistical analysis, regulatory submissions, and secure archival purposes, adhering to data privacy regulations like GDPR and HIPAA, maintaining an unbroken chain of custody.

Our Expertise Includes:

CRF/eCRF Design and Development
Database Validation & Testing with Edit Checks
User & Database Management
eCRF Completion Guidelines and End-User Training
Real-Time Data Cleaning and Query Management

Why Choose Curexbio For Data Management?

Expert Data Team

Experienced in-house data management professionals.

Cross-Team Sync

Seamless collaboration with biostatistics and clinical teams.

Real-Time Cleaning

Proactive real-time data cleaning to ensure timely database lock.

Trusted DM Tech

Use of industry-standard, reliable data management technologies

Request For Proposal

We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Curexbio CRO Expertise

Curexbio Insights Hub

Dive into the latest research, insights, and innovations with our team of experts in the fields that matter most to clinical advancement.

CurexBio specializes in efficient, compliant clinical trials across all phases. We blend scientific expertise with advanced technologies to accelerate drug development. From study design to data management and reporting, our team ensures accuracy, regulatory compliance, and patient safety. With a focus on innovation and collaboration, CurexBio is your trusted partner in turning research into real-world treatments.