Any clinical trial has a variety of moving parts that are instrumental in its success. This starts with the trial design and ends with valuable analysis that helps to provide informed, data-driven outcomes for patients. Effectively designing, deploying and managing these elements requires agility, collaboration and technical capabilities that are best found in a specialist partner. This is why so many trials rely on the support of a Contract Research Organisation (CRO) to carry out their data management and statistical programming.
A great CRO will act as a bridge between the trial sponsors, and the rest of the people involved in the process, such as investigators and consultants, to produce exceptional clinical data deliverables that optimize the success of the trial. But how do you know which CRO to choose to support your study?
What should you look for in a CRO partner?
With a number of full service and specialist CROs to choose from, selecting the right biometrics partner can sometimes seem like a daunting process. It goes without saying that you need to select a CRO that has proven experience in your therapeutic area, and that can deliver the core biometrics services that you need, but there are many more things to consider as part of the outsourcing process.
Here are six top things to look for when selecting a Biometrics vendor for your clinical study.
1 – A CRO that has a team of experts with proven therapeutic, technical and project lead experience so that you know you have the best people on task from the outset
You may have heard the term, “an organization is only as good as its people”. Well, the same can be said for any clinical trial, which requires specialist knowledge, skill and experience to add value to clients and support the end-to-end biometrics process. This includes expertise and capability in areas such as:
- Data Management
- Statistical programming and consultancy
- Interactions and communication with regulatory agencies
- Complex statistical modeling techniques
- Automation and programming
- Real world evidence (RWE) generation and analysis
- Effective governance and due diligence
- Project management
A great CRO is committed to hiring and retaining the best talent in the industry – individuals who are not only highly skilled and experienced, but who are committed to remaining at the forefront of industry developments and passionate in driving the biometrics conversation to improve patient outcomes.
2 – A CRO that has a proven track record of successfully transitioning studies from one vendor to another
In an ideal world, a great biometrics CRO will be involved in the clinical trial process from the very beginning. However, the reality is that sometimes a trial needs interim or emergency involvement from a specialist, agile CRO who can step in and provide a ‘rescue’ service that brings the study back on track.
In this instance, you need a CRO with a proven track record in taking over established studies, who can quickly and effectively work with you to understand your goals and provide a plan to achieve them.
3 – A CRO that takes quality, standards and security as seriously as you do
In the pharma and biotech industry, trust and credibility are crucial, and so you want to know that the CRO you’re considering partnering with has a well established Quality Management System (QMS) in place. A robust QMS shows a commitment to carefully developed processes, compliance with appropriate regulations, and consistency across everything that they do.
When choosing a CRO, you should look for a partner that has well-defined Standard Operating Procedures (SOPs), particularly relating to data governance and handling. They should also have proof of regular audits that show few to no findings, that demonstrate that compliance and standards are always met.
Information security is a key priority for pharma and biotech businesses, as they need to protect intellectual property, preserve data integrity and ensure regulatory compliance. Choosing a CRO that has the necessary certifications and accreditations for information security will give you peace of mind that your data is as safe as possible from cybersecurity risks. An ISO 27001 certification is widely regarded as the best known accreditation for information security and is the accreditation you should be looking for when choosing a biostatistics partner.
And whatsds’s more, finding a vendor who can combine quality, standards, and security with a deep understanding of good clinical practice and plenty of industry expertise will help ensure you get the right CRO support for your project from the outset.
4 – A CRO that makes working with them easy, simplifying all areas of transition including contracting, data transfer, communication and onboarding/training
The decision to change CRO part way through an ongoing study is far from easy. Fortunately, there are some CROs that simplify the process, leaving you free to focus on what’s important – the study itself.
Successful transition needs exemplary communication and collaboration between all parties, starting with a thorough understanding of what has been achieved through the study so far, and what the overall goals of the study are. Access to this data is essential since your new CRO will need to quickly identify any pain points you’re experiencing as well as potential areas of delay and use this information to guide the strategy moving forward. They’ll also need to determine effective workarounds and create new, realistic milestones that keep your trial on track, and ensure that the right people are where they need to be and up to speed so that they can hit the ground running.
Flexible CROs with a personal touch are generally far easier to integrate into a new or existing project from both a strategic and cultural perspective; they can adapt and scale to your needs, whilst retaining a small-business culture that demonstrates passion and commitment, expert knowledge and skill.
5 – A CRO that will partner with you on your digital transformation journey
Technology in Clinical Trials has changed dramatically over the last few decades, with more and more organizations moving towards digitalization to drive efficiency and remain competitive. While you may be feeling the pressure to embrace the latest technologies such as automation and AI, the reality is that many biotech companies need to build their capabilities before they can achieve higher levels of digital maturity. This starts with identifying what you need to have in place, and who better to support you than a biometrics provider that understands both developing technology and clinical practice.
Whether it’s the very first steps in choosing the technologies to support you, or helping your people to understand how to get the very best from the systems you’ve already embraced, it will help to have a reliable partner for your biotech digital transformation journey.
Choosing a CRO dedicated to industry innovation and with a deep understanding and experience of the latest tools and technologies will enable you to scale, react, and deliver more efficiently and effectively, pushing you closer to delivering treatments that change lives.
6 – A CRO that equally prioritizes clients regardless of their company size, market share or the length of their relationship and is committed to building a long-term partnership
No two clinical trials are the same, and you need to work with a CRO partner who treats each one with equal importance. Working culture and establishing strong relationships are core building blocks for the success of any project, and it’s important to select a CRO that doesn’t only echo your own business ethos and priorities but is also passionate about developing a firm foundation for future collaborations.
As a practitioner-led CRO, Veramed perfectly balances highly specialized, expert services with a uniquely personal, collaborative approach to redefining healthcare decision-making to help advance global health.
The final word
Selecting the right CRO can keep your project running smoothly from start to finish. Whether you’re seeking a CRO to support you from the outset, or you need a specialist to step in and rescue a trial that’s struggling, the right CRO partner that is backed by capable, experienced people can help you to produce results that will see faster, more efficient progress towards positive patient outcomes.
”Veramed adds exceptional value as a trusted partner working on our Oncology portfolio. Each team member has performed very well, with excellent support from their management team. Their support has been instrumental in achieving our organizational goals.
Client since 2012
Got three minutes? Find out more about how, at Veramed, we bring people, innovation and technology together: https://youtu.be/MsDV9feoZ24
Got ten minutes? Download our eBook ‘Redefining the Modern CRO’ and discover the key traits and benefits defining a high-performance biometrics CRO.
Want to partner with Veramed? Contact our team today.
