Clinical Trials Outsourcing: We connect pharmaceutical companies with leading CROs (Contract Research Organizations) to manage and conduct clinical trials across various phases. Our partners are known for their robust methodologies, regulatory compliance, and innovative approaches, ensuring efficient and effective trial management.

Bioequivalence Studies: We help you find expert providers to conduct bioequivalence studies, ensuring your generic drugs meet the necessary regulatory requirements and are comparable to the original branded drugs in terms of safety, efficacy, and quality.

Pharmacovigilance Services: We assist in identifying suitable vendors for comprehensive pharmacovigilance services, including Individual Case Safety Reports (ICSRs), medical review, aggregate report writing, signal detection, and risk management. Our partners ensure patient safety and regulatory compliance through end-to-end pharmacovigilance solutions.

Central Laboratory Services: Our network includes premier central labs that offer comprehensive testing services, from routine blood work to advanced genetic and molecular testing, all ensuring precise and reliable data for clinical trials.

Medical Writing: We provide access to experienced medical writers skilled in creating high-quality regulatory documents, clinical study reports, scientific publications, and more. Our medical writing services ensure clarity, accuracy, and compliance with industry standards.

Clinical Data Management: Our vetted vendors offer state-of-the-art clinical data management services, ensuring data integrity, accuracy, and compliance with regulatory standards through advanced technologies and best practices.

Biostatistics & Statistical Analysis: We connect you with leading biostatistical experts who provide critical insights and data analysis for clinical trials, helping to make informed decisions and ensuring the statistical validity of your studies.

Commercial Analytics: Our partners specialize in providing commercial analytics services, including market research, competitive intelligence, and sales forecasting, helping you make strategic business decisions and optimize market performance.

Health Economics and Outcomes Research (HEOR): We offer access to HEOR experts who can help demonstrate the value of your products through cost-effectiveness analyses, budget impact models, and real-world evidence studies.

Key Opinion Leader (KOL) Engagement: Our services include identifying and engaging with KOLs across various therapeutic areas, ensuring that you have the necessary expert input and advocacy to support your product development and commercialization efforts.

Medical Affairs: We connect you with top medical affairs professionals who can manage and execute a wide range of activities, from medical information dissemination to post-market surveillance, ensuring your products meet the highest standards of safety and efficacy.

Regulatory Affairs Services: Our network includes experienced regulatory affairs professionals who can navigate complex regulatory landscapes, ensuring your products meet all necessary regulatory requirements. We assist with regulatory strategy development, submission preparation, and interactions with regulatory authorities.

Other Related Services: We also provide assistance in identifying vendors for quality assurance, supply chain management, and more, covering all aspects of the pharmaceutical, biosimilar, and medical device sectors.

Due Diligence and Compliance Services: At CRQA, we understand the critical importance of due diligence and compliance in the pharmaceutical industry. Our services include:

• Vendor Due Diligence: Comprehensive assessment of potential vendors, evaluating their capabilities, financial stability, and track record to ensure they meet your specific requirements and industry standards.
• Conducting Audits: In-depth audits of vendors to assess their quality management systems, regulatory compliance, operational efficiency, and adherence to best practices.
• Regulatory and Compliance Due Diligence: Ensuring that vendors comply with all relevant regulations and guidelines, including GxP (Good Practice) standards, local and international regulatory requirements, and industry best practices. We provide detailed reports and recommendations to help you make informed decisions.

At CRQA, our goal is to streamline the outsourcing process, providing you with reliable partners who can deliver exceptional results. By leveraging our global network and industry expertise, we help you make informed decisions, ensuring the success of your projects and the advancement of healthcare worldwide.