By Guest Author: Dr. Karin Köhler-Hansner
As a sponsor, do you contract out your clinical trials to a CRO and forget about them? Do you expect that once you sign the Transfer of Obligations form that you can relax and look forward to a perfectly packaged up final study report? You may want to rethink that approach and plan for effective Sponsor Oversight.
Why is Sponsor Oversight Required?
Hundreds of thousands of clinical trials take place around the globe each year. As global trials become increasingly popular and complex, Sponsor companies are partnering more and more with Contract Research Organizations, or CROs, to help manage these trials.
A trial sponsor may hire a CRO to manage some or most aspects of their clinical trials, but the Sponsor’s responsibility for the trial does not end there. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an international body that sets the standards for regulations of clinical trials involving human subjects. ICH guidance state that sponsors must have good processes in place to oversee their vendors, such as CROs, and even the sub-contractors their vendors.
The COVID-19 pandemic has affected many generally accepted clinical research systems and processes, including on site monitoring, meetings, on site auditing, and paper-based documentation. Sponsor oversight plans and processes must adapt to the new remote work arena.
What Does Sponsor Oversight Involve?
Although many clinical research study tasks may be outsourced to CROs or other vendors, the sponsor remains ultimately responsible for the projects and their outcome. In broad strokes, sponsor oversight includes verification of the delegated clinical research responsibilities to assure data integrity and patient safety.
Certain technologies and processes are helpful for efficient sponsor oversight in clinical trials. Let’s review a few of these now:
A Risk-Based Approach
With a risk-based approach, a sponsor creates a plan to check on certain trial activities with a defined scope and at defined intervals. For example, the sponsor may have a plan which includes a spot check of 10% of the trial master file documentation every 3 months. During a planned check, the sponsor may discover an issue or error. The sponsor should then increase oversight activity. After quality improves, they can return to the original spot check plan.
Invest in Good Documentation
There is a saying in clinical research: “If it was not documented, it did not happen”. Many sponsors make the mistake of not documenting their oversight checks. A lack of documentation can put a sponsor at risk of non-compliance as well as cast doubt on the clinical data generated.
Managing clinical trials takes a great deal of work and involves many people and processes. Documentation of quality checks and findings will help ensure that mistakes are not repeated and the data from the trial are reliable. Sponsors should invest time in high-quality documentation. Excellent documentation can help them avoid pitfalls in clinical trial management.
Utilizing Key Technologies
In the past decade, there has been an acceleration in the development of clinical trial computer systems. The most commonly used systems include Clinical Trial Management Systems (CTMS), electronic case report forms (eCRF), electronic data capture (EDC) and electronic trial master files (eTMF). Whether the sponsor or the CRO manages and administers any of these systems for a clinical trial, the sponsor should have access to and review regularly the data contained within the system(s). Most modern technology systems capture audit trail data which can help with documentation of sponsor clinical trial oversight.
Sponsor Oversight in the Age of COVID-19
COVID-19 has transformed the clinical trials landscape. Most notably, the pandemic has limited onsite monitoring. When CRAs cannot physically visit sites, source data verification (SDV) is a big challenge. Regulations regarding remote source data access and verification vary between countries.
Some countries, such as the U.S. have been very successful with allowing remote SDV while complying with privacy rules. Other countries lag behind in their digital technology and/or have prohibitive data regulations. Germany has been slow to adopt remote review of electronic medical records due to a very strict data protection guideline. Video consultation has also been difficult in the country.
Overall, life science companies have adapted well to the pandemic since most companies were already using electronic systems which are purpose built for remote work. The pandemic has proven how valuable these technologies have become to the clinical development industry and sponsor oversight.
Collaboration Toward Success
A strong Sponsor-CRO relationship and sense of partnership is a key to a successful clinical study. Good communication and clear set of expectations will help the trial run more smoothly and make sponsor oversight efficient and effective. All of the available digital tools can help make the clinical trial process more transparent, but human to human interactions are still important to discuss sponsor oversight findings and gain insight into processes and plans.
Taking Your Project to the Next Level
If you want to accelerate your digital transformation for your clinical trials, expedite the startup process, or simply cut costs, SureClinical is here for you.
Our unified cloud-based software solutions, including eTMF, eISF, CTMS, QMS and digital signing, are designed to streamline clinical operations and help our customers achieve efficiency and minimize risk.
We commit our experience in clinical trials management to helping our clients achieve success.
If you’d like to learn more about what SureClinical can do for you, get in touch! We look forward to working with you.
About Karin Köhler-Hansner
As a trained biologist with a PhD in cancer research Karin started her career in clinical research as a Freelance CRA. Soon thereafter she joined one of the major globally acting pharmaceutical companies as Clinical Study Manager in various indications and with a passion for quality and training. Due to a very focused and structured work attitude and being able to provide quick decisions and recommendations Karin moved into positions of increased responsibility.
During the last five years Karin gained extensive European and Global experience by performing quality visits in the EU and the US. In 2019 Karin founded her own company, AH Clinical Trials Services GmbH (AHCTS). One of the key services is providing sponsor oversight mainly in the indications Rare Diseases and Oncology. Additionally, AHCTS offers GCP-trainings and consults on processes regarding Sponsor Oversight, Risk Management and Clinical Trial Management.
If you have any questions about sponsor oversight and how to improve your operational processes, please reach out to Karin at:
Phone: +49 170 1238693