Over the past year, there have been many buzzwords thrown around the industry: ICH GCP E6 (R2) addendum, risk-based approach, vendor oversight, data anonymization, GDPR. What makes SME clinical vendor oversight a particular challenge?
Recent industry changes can be summed up into one general concept: regulatory authorities and international standards are cracking down on data quality and integrity making the clinical trial Sponsor ultimately responsible for compliance.
Larger pharmaceutical and medical device companies are better equipped to deal with these changes. They have the internal resources – both in terms of capital and human resources – to assess risk and implement programs and technologies to ensure vendor oversight and comply with regulations.
Small to Medium-sized Enterprises (SMEs) may face bigger challenges. Smaller companies might only have a few products (or some cases only one product) in their pipeline, which means they have one chance to get it right.
SMEs should build themselves a checklist, or a toolkit of resources, when it comes to planning clinical trials in a new era of regulation. More importantly, how can SMEs ensure their vendors are compliant as well?
- Know your study needs as an SME
Where am I going to conduct my study and what are the data transfer and privacy requirements?
With which regulatory authorities am I going to have to interact?
Which standards do I need to apply to my study?
How are these requirements going to affect my study design and methodology?
We know there are several international standards that SMEs will need to follow. For example, the ICH GCP E6 (R2) guidelines and addendum, which came into effect in 2017, require a risk-based approach to clinical trials and make the Sponsor ultimately responsible for clinical trial conduct. SMEs should be asking themselves if they have a risk-based Quality Management System in place to ensure compliance.
Both the EMA and FDA are advocates of data transparency in clinical trials and have pushed through legislation and pilot programs. These regulations will have an effect on your study design, and therefore involving a biostatistician and possibly an expert Data Manager from the start can help ensure the trial is designed with these considerations in mind.
For scientific and regulatory advice the European Medicines Agency has an initiative geared specifically towards SMEs. Vendors can also be qualified as SMEs to help companies with access to Scientific Advice and other SME benefits.
- Know the best outsourcing strategy for SME needs
To ensure vendor oversight, companies need to rely on study metrics and data analysis. SMEs should consider centralizing their data with a specialized vendor. In this approach, the SME can keep data management, statistics and programming as well as medical writing within one company to ensure traceability of data and establish a metrics and communication plan. This also allows SMEs to better deal with changes to study design and stay on track in terms of timelines and budget.
SMEs should also evaluate whether a Functional Service Provision model could be appropriate. In this model, companies can contract a scalable team of expert resources by function for specific projects. The work can be done remotely or on-site. Data Managers, Statistical Programmers, Statisticians, Medical Writers and Regulatory and Quality Assurance professionals could all be contracted under an FSP contract. In this case, the vendor is responsible for training and human resources aspects. The resources would work as an extension of the SME’s team and therefore it would be convenient to manage vendor oversight.
- eClinical tools and solutions for SME Clinical Vendor Oversight
In order to comply with international standards and regulations and ensure vendor oversight, eClinical tools are a must. SMEs need to budget in advance for tools such as EDC systems and data visualization tools that allow for real-time data analysis. If SMEs are also planning on submitting a New Drug Application or Marketing Authorization Application, they will need to think about the de-identification and anonymization of data. For SMEs working with data in the European Union and/or transferring data between the EU and other countries, they will need to think about compliance with GDPR and data privacy.
Here are some considerations:
- Have I found an EDC system that meets my study and budget requirements? Is it compliant with GDPR?
- Where is the database located? Which data privacy and protection laws must I be compliant with?
- Am I considering a submission for market? Will I need a tool to redact patient identifiers and anonymize data?
- How am I monitoring site data?
- Do I have a tool for viewing and analyzing data handled by vendors?
- Can my vendor provide the necessary tools?
- Who will manage my eClinical tools as well as my data?
How can CROS NT support SMEs? Send us a request for information.