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.

Staying on top of drug safety.

Drug safety and pharmacovigilance professionals are increasingly challenged, having to do more with less. The key to your success is implementing automation, adopting advanced technologies, and leveraging insights from analytics that improve compliance and product safety. Curexbio provides flexible, innovative, scalable solutions to meet your unique business requirements.

CurexBio's Inclusive Pharmacovigilance Services

CurexBio offers a full suite of highly flexible, innovative, and scalable pharmacovigilance services, designed to meet your unique needs from early development to post-marketing surveillance. Our technology-driven approach and experienced team ensure accurate and efficient management of adverse event data, minimizing risk and upholding regulatory compliance.

Adverse Event (AE) / Serious Adverse Event (SAE) Management

Our core pharmacovigilance service includes comprehensive Adverse Event (AE) and Serious Adverse Event (SAE) management. This involves:

24/7 Case Intake: Establishing mechanisms for prompt receipt of safety information from all sources globally.
Case Triage and Data Entry: Efficiently triaging incoming cases and accurately entering data into validated safety databases.
Medical Coding: Standardized coding of medical events and drug information using MedDRA and WHO Drug dictionaries.
Quality Control & Reconciliation: Rigorous quality control checks and reconciliation with clinical trial databases to ensure data consistency and accuracy.

Expedited & Aggregate Reporting

Timely and accurate reporting is paramount. We specialize in the preparation and submission of all necessary expedited and aggregate safety reports, including:

SUSARs: Expedited reporting of Suspected Unexpected Serious Adverse Reactions to regulatory authorities and ethics committees worldwide.
DSURs (Development Safety Update Reports): Annual reports for investigational products in clinical development.
PSURs (Periodic Safety Update Reports) / PBRERs (Periodic Benefit-Risk Evaluation Reports): Regular post-marketing reports summarizing the worldwide safety experience of a marketed product, including its benefit-risk profile.

Signal Detection & Risk Management

Our proactive approach to drug safety includes advanced signal detection and risk management. We continuously monitor safety data to identify new or changing safety signals, evaluate their significance, and assess their impact on the product’s benefit-risk profile. This includes:

Signal Validation: Confirming potential signals through further analysis.
Risk Management Plans (RMPs): Drafting, reviewing, and implementing comprehensive RMPs to identify, characterize, and minimize risks.
Risk Evaluation and Mitigation Strategies (REMS): Where required, developing and managing REMS programs to ensure safe use of certain drugs.

Medical Review and Causality Assessment

Our safety physicians offer expert medical review and causality assessment for individual case safety reports, evaluating the relationship between adverse events and investigational products, crucial for regulatory reporting and benefit-risk assessment.

Safety Database Management

We leverage advanced safety databases like Argus and ArisG for secure, efficient management, ensuring data integrity and compliance with 21 CFR Part 11 and ICH E2B standards. Our expertise also includes setting up and maintaining PV systems to meet regulatory and operational requirements.

Audits, Inspections Readiness & PV System Support

CurexBio guarantees consistent compliance with Good Pharmacovigilance Practices (GVP) by promoting PV audits, internal audits, inspection readiness, mock inspections, vendor/affiliate audits, training, and on-going support for PV systems, encompassing SOP writing, targeted training, and regulatory updates.

Pharmacovigilance for Clinical Trials

Managing safety databases efficiently to ensure robust data integrity
Handling case management duties including tracking and analysis of safety reports
Conducting medical coding for accurate categorization of trial data
Preparing and submitting safety reports like SUSARs, PSURs, and DSURs
Performing global literature searches and reviews to support safety assessments

Pharmacovigilance for Post-market Studies

Detecting signals to identify potential safety issues post-marketing
Supporting protocol development with safety data insights
Drafting and reviewing risk management plans to ensure ongoing safety
Screening literature for additional safety information post-launch
Managing safety reporting for individual case safety reports and aggregate reports

Comprehensive Pharmacovigilance

Setting up and managing PV systems to support comprehensive safety monitoring

Maintaining PV systems to ensure they meet regulatory and operational requirements

Supporting system audits to validate data integrity and compliance

Ensuring data security and safe transfer of sensitive information

Providing regulatory support for all safety reporting needs

Support Services Outsourcing

Writing and updating SOPs to ensure best practices in pharmacovigilance
Delivering targeted training services to enhance team competence in safety processes
Keeping up with regulatory updates to maintain compliance
Conducting monitoring and audits/inspections to ensure continuous improvement
Outsourcing system management tasks to streamline operations

PV Audits and Training

Conducting internal audits to assess pharmacovigilance practices

Providing training and mock inspections to prepare teams for regulatory audits

Supporting audit and inspection readiness across the organization

Managing vendor and affiliate audits to ensure third-party compliance

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.