Clinical Trial Support – 5 Reasons Why You Don’t Have To Do Everything Yourself

Clinical Trial Support – 5 Reasons Why You Don’t Have To Do Everything Yourself: 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 retain oversight of the project and make the decisions while bringing in experts to support you in various aspects of the clinical trial process. This kind of clinical trial support 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 clinical trial 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.

This is especially applicable in an FSP partnership, which offers flexibility in terms of budget as well as support (see point 5 for the details).

4. You’re More Likely to Succeed with Clinical Trial Support

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. CRO services 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 provide clinical trial support for as long as you need, including to help you beyond the trial, to ensure your data are reliable and you get the most out of publication.

5. Clinical Trial Support That Provides Flexibility

CRO solutions increasingly include Functional Service Provider (FSP) models, which offer the kind of flexibility sponsors, especially small biotechs and pharmaceutical companies, need. Clinical trial functional services, such as providing experts for clinical monitoring or data management, allow the sponsor to remain in control of the whole clinical trial process, while providing the CRO services they need at the right time.

One of the added benefits of the FSP approach is that, as a sponsor, typically get support from more experienced experts than you might do with full-service CRO solutions from a big company. In the latter arrangement, more junior staff may be assigned to a clinical trial that the CRO is contracted to manage in its entirety. In contrast, with FSP, the sponsor controls the functions or tasks they need support with, and CROs are more likely to assign senior staff who have more experience and expertise.

Clinical trial functional services not only take on some of the workload for a sponsor, but they also open the door to specific expertise you may need at certain points during the trial, such as regulatory submission or clinical monitoring. This enables you to enrich or streamline your team as the trial progresses.

Siron Clinical Can Support You

At Siron Clinical, we provide CRO services with expert clinical trial professionals who have 15 years of experience across a range of therapeutic areas. Our experts work seamlessly with your team to help you succeed with your trial. We offer clinical trial 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.

Clinical trial support from Siron Clinical can help you manage your clinical trial, budget and timeline. Find out more about our flexible Functional Service Provider (FSP) options and contact us to get started.