Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D) requirements to health authorities is a critical decision. The vendor selection process varies greatly. Some organizations have rigorous prescribed procedures, while others boast a less formal, less structured process. You need to select a vendor who will help to maintain regulatory compliance and complete anonymization/redaction on your drug program’s regulatory documents in a timely manner, no matter how large the submission dossier. They must be current on global T&D requirements and understand the ever‑changing regulatory landscape across Health Canada (HC), European Medicines Agency (EMA), and other regulatory authorities. Remember that the disclosure of clinical data is a requirement, not an option, under the major global health authorities’ regulations.
To guide your decision-making process, we’ve provided a checklist that highlights what to look for in vendor. Download it here. This checklist explains how to choose a strong vendor that provides robust solutions will best support your needs.
Enterprise features, including integrated service offerings
One of the greatest benefits of using a vendor that acts as your comprehensive T&D partner is that you only need to use one! Certara’s T&D team is composed of Transparency Specialists, biostatisticians, and Quality Control specialists who support anonymization through technical expertise (such as risk assessment) and consultation (such as identification of commercially confidential information; CCI). Our approach driven by collaboration, financial accounting, partnering, and cohesiveness supports your current and long-term needs.
Reliability and trust / Team with deep knowledge and expertise (strong credentials) / Specialized consulting and regulatory expertise
Select a vendor with a strong reputation and references that verify its quality. Case studies, testimonials, and clients you can contact as references are all important assets that can direct your decision-making. Certara has been supporting EMA Policy 0070 and 0043 submissions since these regulations were enacted over a decade ago (read about our approach to Policy 0070 compliance in this blog). Our services continue to evolve considering new regulations, as they impact past work, current support needs, and future requirements (for example, check out this blog on the new EU Clinical Trial Regulation 536/2014 [EU-CTR]).
Our experience and standard ruleset backed by years of experience and agency interactions allows us to help clients meet tight timelines. We tailor our proven anonymization approach to your clinical studies. You can read our submission success stories here.
Our T&D team has expertise not only in anonymizing data but can also harness technology to build efficiency and improve consistency across documents. Every project lead and team are consistently assigned, so that our clients work with the same lead and team from start to finish. Real-world advice on strategy and expertise in your therapeutic area, especially as it related to data utility, are just some of the perks of working with our team.
Round-the-clock publishing support, including global operations / Flexibility and scalability
Meeting an impending timeline, whether a regulatory health authority body request for data disclosure from a retrospective submission or the rapid need to anonymize data while preparing an initial submission, can be daunting. Select a vendor that can seamlessly move your project forward.
Certara‘s global resources in the US, Europe, Canada, and APAC scale up or down as needed to support a submission, making it possible to meet challenging deadlines. Moreover, we’re continuing to expand our Transparency and Disclosure team and its technology to adapt to an evolving industry.
Clear and comprehensive contract/work order
Working under a contract that allows for flexibility, additional considerations, and overall confidence in the project may provide peace of mind at a project’s onset. Certara’s services and technology support complement one another in every project. Each project starts with collaboration and open communication during the contracting phase and going straight into kickoff. Our team works with you in a clear and customized approach so that your project can be successful.
Support on pre-submission meetings and incorporation of post-agency feedback
Imagine you just received a request from the EMA for a redaction package under Policy 0070. You’re unsure where and how to start, especially when determining which documents are in scope. Certara’s Transparency Specialists and the Project Lead can accompany you on a pre-submission meeting with the EMA to discuss the clinical data publication process/timelines and to finalize the list of in-scope documents. After the final redaction package is submitted, the health authority may have comments or items to adjust. By working with a vendor who can quickly and efficiently incorporate those comments, you can eliminate the need to re-engage your internal team and alleviate any undue stress caused by the feedback. Our team has a timely and effective process for implementing agency feedback, which pulls upon global resources and technology to create the final product for re-submission.
Technology can save time and improve quality/accuracy to ensure every piece of patient or CCI in your clinical trial documents is anonymized appropriately (read more about how to identify CCI in this blog). When anonymizing thousands of pages of documents, or even just a few, it becomes critical that technology not only meets rigid timelines but makes the work manageable for teams of any size.
Certara’s anonymization tool, utilized by our internal team and accessible for document transfer through a web portal to our clients, ensures that we’re exceeding the quality and consistency standards typical of manual anonymization. Our tool’s artificial intelligence, backed by machine learning and natural language processing, does the hard work of transforming the data in your documents for you.
Strong user authentication and advanced security
A prospective vendor should prioritize security and can demonstrate its software applications have been validated and certified. Certara’s web-based anonymization tool uses Advanced Encryption Standard (AES-256) encryption for data at rest and at transfer to secure all your projects.
Strong company overview, including solid financials
Select a company with market leadership and broad industry expertise. This includes sound financial health and a track-record for success, especially in the data anonymization and redaction space. Our Transparency and Disclosure team at Certara has anonymized >15 million report pages to date.
Pharmaceutical and biotech companies continue to rely on vendor services to meet their transparency and disclosure requirements, and this reliance is growing. Partnering with the right vendor may be the difference between a quality, approved submission or an inconsistent, rejected one. Utilizing a vendor evaluation checklist will help you identify the provider with the right people, best procedures, and most efficient tools/technology to get the job done.