Clinical trials are complex, which means they involve a lot of work and require a range of skills and experience. It can be daunting when you start planning a clinical trial – how will you manage everything that’s needed, especially if you have a small team?
One answer is you don’t have to. As the sponsor, you can have oversight of the project and make the decisions and bring in experts to support you in various aspects of the clinical trial process. This can reduce the burden on your team, improve your results, and even save you time and money.
Here are five reasons why you don’t have to do it all yourself.
1. You Can Bring In All The Expertise And Skills You Need
Recruiting the right team members is challenging and takes time. If you have a solid team already, recruiting new people temporarily to help run a clinical trial can be a drain on resources – and you might not have the budget to hire in-house.
When you work with a clinical trial support partner – a contract research organization (CRO) like Siron Clinical – external experts join your team for the duration of the trial. A CRO team generally has expertise across a range of therapeutic areas, trial types and aspects of clinical trial management. You can choose the level of support they provide – for example, if your team already has clinical monitoring capability but needs help with project management and regulatory issues, you can work with a CRO on those aspects.
2. You Can Save Time…
Wherever you’re planning to run your clinical trial, the application process can stretch out, taking months or even years before you recruit the first participant. This is often because of mistakes made during the process. With support from regulation experts, you’re less likely to waste time on administrative mistakes.
For example, does your team know the regulatory agencies involved in the trial process around the world, their roles, their requirements and their timelines? The agencies themselves can be a source of confusion (EMA, FDA, NIHR, OHRP, IRB…) but understanding their roles in ensuring clinical trials are run properly and safely is vital to ensure your success.
3. … And Money
When you establish a clinical trial support partnership with a CRO, you’re ensuring your clinical trial is run as cost-effectively as possible:
• You don’t face the expense – both in terms of time and money – of hiring new team members.
• You work with expert project managers who identify opportunities to improve cost-effectiveness.
• You reduce mistakes and therefore save time and money in the application process.
• You work together during the trial process and can end the partnership when you no longer require support.
4. You’re More Likely To Succeed With Help
In our RFI, we share three keys to success in clinical trials: a European edge, local knowledge, and high-quality work.
Clinical trials run in the EU work differently to those in the US; having an in-depth understanding of the differences can help you succeed in Europe.
For international clinical trials, teams often don’t have the local knowledge they need in-house. For example, EU legislation requires trial sponsors to apply in each country and at the European level. This means you need expertise in the trial regulations in each country in which you’re planning to run the trial, as well as local language skills. A CRO can bring this to your team.
And to be successful, you need to ensure high quality in your work, from application through clinical monitoring all the way to data collection and analysis. A CRO can help you beyond the trial, to ensure your data are reliable and you get the most out of publication.
5. Siron Clinical Can Support You
At Siron Clinical, we work seamlessly with your team to help you succeed with your trial. We offer support with:
- Project Management, including developing and tracking study timelines, ensuring all activities are within scope and budget, coordinating and executing Clinical Trial activities and acting as the central point of contact for the client.
- Clinical Monitoring, including protocol, regulatory and ICH GCP compliance verification, site personnel training and pharmacovigilance: assisting and ensuring appropriate reporting of CIOMS, DSURs, annual IDB updates.
- Quality Assurance / Control, including clinical study document review, accompanied site visits and inspection preparation site visits.
- Regulatory Submissions, including regulatory advice, preparation and submission of dossiers, and acting as EU Legal or Data Controller representative.