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Selecting a CRO for PV Literature Surveillance Services

Ensure compliance with PubHive's Safety & Regulatory solutions. Streamline workflows, enhance drug safety, and meet global regulatory requirements seamlessly.

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Selecting a CRO for PV Literature Surveillance Services

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  1. We Offer Quality, Commitment And Customer Satisfaction Selecting a CRO for PV Literature Surveillance Services +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  2. About Us • We are a cloud-based software-as-a-service (SaaS) company with offices in the United Kingdom (UK), United States, and India. • At PubHive, we are dedicated to revolutionizing the life sciences industry through intelligent workflow automation solutions. Our mission is to empower research and compliance teams with cutting-edge tools that streamline processes, enhance efficiency, and ensure accuracy in every step of their journey. • Our mission is to make healthier scientific literature and information pathways for life science companies of all sizes across all stages of the commercialization lifecycle – from discovery to post-market. • Our management team possesses more than 40 years of combined hands-on expertise in architecting and delivering software solutions to 84% of the world’s top-25 life science companies, dozens of medical device and diagnostics companies, and hundreds of start-up biotechs. +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  3. Selecting a CRO for PV Literature Surveillance Services • As a safety professional in the highly regulated pharmaceutical and biotechnology industries, you intimately understand the important role that teams like yours own for ensuring the post-market safety of drugs and biological products. You also understand that ensuring safety requires continuous improvement of processes for effectively detecting, assessing, and preventing adverse effects of medicines. • One critical aspect of pharmacovigilance is literature surveillance and monitoring, which involves monitoring published journal content to identify any safety concerns related to your company’s products. +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  4. Critical-to-Success Factors • Language Capabilities: When outsourcing pharmacovigilance literature surveillance services, it is essential to ensure that the CRO can monitor literature in the local languages of the countries where your products are sold, either directly or with a strong network of local literature partners. This will ensure that all safety-related information is captured and reported accurately. • Experience: When selecting a CRO, look for a company with a track record of conducting pharmacovigilance literature surveillance. For CROs that have relatively new PV literature surveillance offerings, closely examine the breadth and depth of experience of the management team and operations team. Be sure to also scrutinize their technology stack to ensure they are using PV literature automation software and how it works, as this may offer advantages even over larger more established competitors who may not yet have implemented transformative technologies into operations. +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  5. Customer Focus: Choose a CRO that is responsive to your needs and works with you to tailor their services to meet your specific requirements. A customer-focused CRO should be transparent and communicative, informing you of any issues, and providing timely and accurate reports. Small and medium-sized boutique CROs often provide a more high-touch experience, offering greater value for your outsourcing investment. In either case, the CRO should assign a dedicated team to work on your project, ensuring that you have a consistent point of contact throughout the engagement. • Reputation: When selecting a CRO, reputation matters. Do your research and ask for references and reviews from past clients. An established CRO should have a strong reputation in the industry and be known for delivering quality pharmacovigilance literature surveillance services. The CRO should also have a robust quality management system in place to ensure that all work is completed to a high standard. +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  6. PV Literature Technology: Advancements in automation technologies have revolutionized the pharmacovigilance industry, enabling faster and more accurate analysis of large volumes of literature data. Be sure to assess if these technologies are applied across global literature surveillance activities that involve databases like PubMed, Embase, and Ovid, and if automation technologies are also applied to local literature monitoring activities as well. • Third-party software can also provide manufacturers with more PV literature vendor oversight and relationship flexibility. For example, PubHive's drug safety and pharmacovigilance (DSPV) software platform, which is designed for simultaneous use by external vendors and internal safety teams, can automate the process of monitoring and analyzing literature, reducing the risk of errors, while saving time and closing oversight gaps. • Regulatory Compliance: When outsourcing pharmacovigilance literature surveillance services, it is essential to ensure that the CRO adheres to all regulatory requirements. +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  7. The CRO should have a robust quality management system in place and be experienced in working with regulatory bodies such as the FDA, EMA, and PMDA. The CRO should also have a thorough understanding of pharmacovigilance regulations in the regions where your products are sold, ensuring that all relevant safety information is identified and reported. DSPV literature software like PubHive Navigator can dramatically help with regulatory compliance and governance.It can also provide peace of mind by boosting audit and inspection readiness. • Data security: Pharmacovigilance literature surveillance involves handling sensitive and confidential data. It is essential to select a CRO that has robust data security protocols in place to ensure that your data is secure. The CRO should have policies and procedures in place for data handling, storage, and transfer, and be compliant with. +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  8. Conclusion • By considering these factors, you can find a CRO that will provide reliable and effective pharmacovigilance literature surveillance services on behalf of your company. With the right partner, you can ensure that you are meeting all regulatory requirements and keeping your products safe for consumers. • If you Want to learn more Contact PubHive today if your life science company would like an introduction to CROs that are leveraging PubHive’s fit-for-purpose DSPV literature platform or if you’d like to see what our platform can do for you safety team. Contact Us +1 617-657-4781 20-22 Wenlock Road, London N1 7GU, UK www.pubhive.com

  9. Contact Us Contact No +1 617-657-4781 Website Link www.pubhive.com Address 20-22 Wenlock Road, London N1 7GU, UK

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