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.

Central Laboratory Support

Adhere to global regulatory norms and offer end-to-end support to ensure quality compliance across all phases of clinical development.

CurexBio's Comprehensive Central Lab Support Services

CurexBio offers a full spectrum of integrated Central Lab Services, meticulously designed to support your drug development pipeline with unparalleled accuracy and efficiency, seamlessly aligned with our Bioanalytical Support and Quality & Compliance operations.

Strategic Sample Management and Global Logistics

The integrity of your data begins with the integrity of your samples. We provide robust sample management and logistics solutions, covering every step from collection kit supply to long-term storage. Our services include:

● Customized Kit Production: Designing and supplying bespoke collection kits tailored to specific study protocols and sample types.

● Global Logistics and Shipping: Managing complex international and domestic shipping, ensuring temperature control and compliant transport of biological samples.

● Sample Processing and Archiving: Expert handling, processing, and secure, auditable long-term storage of samples (e.g., plasma, serum, urine, tissue) in biorepositories, accessible for future analysis.

Advanced Analytical Testing and Biomarker Analysis

Our central lab potential involves a wide range of pragmatic analytical testing. We utilize state-of-the-art technology and validated methodologies to perform critical assays validated methodologies to perform critical assays including PK / PD, following FDA Bioanalytical Method Validation guidance:

● Pharmacokinetic (PK) and Pharmacodynamic (PD) Assays Essential for characterizing drug absorption, distribution, metabolism, and excretion, as well as its effect on the body. This is particularly critical in preclinical phases and early-phase clinical dosing studies.

● Biomarker Analysis: Identifying and quantifying specific biomarkers that indicate disease progression, treatment response, or potential toxicity, crucial for precision medicine.

● Clinical Chemistry & Hematology: Standard safety testing for comprehensive patient monitoring.

● Immunogenicity Testing: Detecting and quantifying anti-drug antibodies, vital for biologic drug development.

● Ligand Binding Assays (LBA): For analysis of large molecule therapeutics.

Seamless Data Harmonization and Robust Reporting

Ensuring that data from multiple sources is consistent and easily interpretable is a core strength of our Central Lab Support aligned with Data Management and Bio-Statistics workflows for standardized integration.. We implement rigorous data harmonization processes, translating raw lab data into standardized, clean formats that integrate seamlessly with your clinical databases. Our robust reporting capabilities provide:

● Real-time Data Access: Secure, online portals for investigators and sponsors to access lab results promptly.

● Comprehensive Reports: Clear, concise, and regulatory-compliant reports that present data meaningfully for analysis and submission.

● Query Management: Proactive resolution of any data discrepancies or queries to maintain data integrity.

Uncompromising Quality Assurance and Regulatory Compliance

Quality is woven into every aspect of CurexBio’s Central Lab Support. Our facilities operate under strict Quality Assurance protocols and adhere to the highest global regulatory standards:

● GLP (Good Laboratory Practice): For preclinical services ensuring the integrity and reliability of non-clinical safety data, crucial for dosing studies and toxicology.

● GCP (Good Clinical Practice): For clinical samples, ensuring ethical and scientific quality.

● CLIA/CAP (Clinical Laboratory Improvement Amendments / College of American Pathologists): Where applicable, ensuring high standards for clinical testing.

● ISO Certifications: Confirming a strong responsibility to international quality management systems.

● Robust Audit Trails: Maintaining comprehensive documentation for full traceability and audit-readiness.

Our Expertise Includes:

Why Choose Curexbio For Central Laboratory Support?

Unified Lab Solution

One-stop central laboratory solution for streamlined, standardized data.

Integrated Lab Ops

Integrated systems and expert coordination for reliable study execution.

Timely reporting

Fast report delivery to inform sponsors and facilitate effective decision-making.

Seamless Study Flow

Our team ensures smooth operations by maintaining communication with sponsors and laboratories, allowing for swift decision-making and minimizing potential study disruptions

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.

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1113, Silver Radiance 4 Sarkhej – Gandhinagar Hwy, Chanakyapuri, Ahmedabad, Gujarat 382481
bd@curexbio.com
+91 8905818034
+91 7784847766
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