Author Archives: Vanessa

Clinical trial supplies

How to identify and manage risks in clinical trial supplies

Running a successful clinical trial relies heavily on the management of risks within the supply chain. Risk management is an essential part of clinical trials to ensure you can generate a clear return on investment without disruptions. It’s a complex process of identification and management depending on a number of factors that can impact the effectiveness of the trial. There is no one size fits all approach. Each clinical trial has its own complexities based on the comparator, data, stock shortages which can delay timelines and increase costs. Mistakes can prove very expensive and more importantly, put patient safety at risk.

Successful clinical trials need effective supply chain management procedures to make sure risks are identified and managed in a timely manner so the required medication is available at the site when needed. Taking a holistic approach to assessing and managing risks makes sure you can prevent things that will impact the trial and the data generated. There needs to be a robust methodology in place for identifying, evaluating, and proactively managing the risks involved in clinical trials.

So, what are the risks involved in clinical trial supplies and how can you manage these risks to ensure a successful clinical trial?

Phases of clinical supply complexity

Looking at the different phases of the study and the complexities each one encompasses is a great way to identify where risks may arise.

Phase 1 is characterised by a small group of subjects, short-duration and limited distribution. Within this phase, the amount of investigational medicinal product (IMP) can vary depending on the dosing scheme, with a possible increase of up to two or three times more than the original by adding just another subject for example. The product shelf life is still up for review and data will confirm this as it becomes available throughout the study. Costs and duration tend to be lower in this phase than the others due to limited scope and therefore limited resources are required to manage clinical supplies.

Phase 2 is made up of hundreds of subjects and studies can last over months or years. The study can expand into a number of regions and sites which introduces treatment arms that bring with them their own challenges. In this phase, an Interactive Response Technologies (IRT) platform is used to look after randomising and dispensing. Packaging campaigns are also needed to account for country-specific labels in the local language. At a trial in this phase, risk management must be prioritised to ensure costs and timelines are aligned.

Phase 3 involves hundreds and even thousands of subjects with a study duration lasting up to four years. Trials are held at clinical sites across the world spanning multiple regions and countries. The phase 2 challenges still stand in phase 3 but are exaggerated because of the scale of the study. With global studies, differences in how the trials are conducted and managed require more thought. Particularly into the required documentation that differs from countries and continents. At CSI, we run studies with 35+ different medications in many countries. To ensure successful delivery, we spend significant time planning and evaluating supplies.

Clinical Trial Supply Stages

Managing risk in clinical trial supplies 

The risk management process can be carried out in six clear steps from identification to reporting. While there may be some additional actions taken within the process such as time and resources, the benefit of having detailed risk management ensures your costs and data can be protected.

Identify risks

Knowing which risks to identify before conducting clinical trials is the first step in risk management. Specific characteristics of the trial design and drugs can lead to different risks that make the process complex. This requires critical thinking from team members to understand where risks can occur, the severity of the risks and the controls involved. Specific comparators are studied in terms of availability, shelf life, handling conditions, distribution requirements and paperwork. 

Evaluate risks

The risks should be evaluated to ensure they’re prioritised effectively. Look at how likely the risk is to occur in this specific trial and what level of risk it poses to the success of the trial. The risks that are likely to occur and would have a moderate or high impact on trial success should be acted on first and foremost. Using a risk impact matrix is a useful tool to achieve this. Place the risks on a likelihood scale from rare to almost certain, with consequences ranging from insignificant to catastrophic. You could categorise them as low, medium or high risk to decide which risks must be controlled as a matter of priority. At CSI we always develop contingency plans and critically evaluate comparator sourcing related risks.

Control risks

Putting control procedures in place will ensure the trial risks don’t turn into issues. Risks must be controlled to prevent them from occurring and having consequences on the trial itself. How you decide to control the risks involved depends on the design of the trial and the drugs used. Think about if you will be using an IRT, if the study is blinded, what resupplies will be needed, is there enough internal resource available at each trial stage? These are the types of questions that should be addressed to put actions into place at the right stages of the trial.

Communicate risks

An aligned team is essential to ensure trial risks can be identified, monitored and managed effectively. Communicating internally will make sure everyone understands the elements of the trial, the risks involved and the controls that are in place to prevent them. Communicating externally is essential too; sponsors, vendors and stakeholders must have the relevant risk information to track the progress and conduct of the study. We appreciate that nobody likes surprises that can impact study timelines. When medicines are unavailable, we scan the entire global market to provide timely solutions.

Review risks

The risk management plan should be updated in line with the trial to track changes to the known risks and if any new risks arise during conduct. Look closely at whether the control measures put in place are working effectively and if the risks that had a high likelihood of occurring are being prevented. If they’re not, what else can be done to make sure they don’t occur? This requires resources on hand to document the mitigation’s during the conduct of the trial to make sure critical thinking isn’t overlooked.

Report risks

The final stage is reporting on the trial and its process. What were the objectives of the study, what was the design of the trial, who was involved internally and externally? Based on these factors, what were the risks that had a likelihood of occurring and what was the consequence of the trial if they happened? If the risks weren’t mitigated by the control measures and the issues occurred, what impact did it have on the trial and data validity?

The key to effective risk management is being proactive. Using critical thinking to identify risks involved in clinical trial supplies and evaluating the impact they could have on the trial if not controlled. Managing risks ensures they don’t become expensive problems and that high quality, valid data can be gathered throughout the trial. Reviewing and reporting on the conduct of the trial and the risk management process ensures you’re best positioned to achieve your trial outcomes.

Contact CSI to discuss how we can deliver a detailed, zero-tolerance risk management approach for your clinical trial supplies.

Comparator sourcing

The one question you should ask your comparator sourcing partner

How can you be sure that your comparator sourcing partner will provide you with the best available solution? How do you know that the company has a truly global reach? How do you know whether your partner could save you hundreds of thousands of pounds, or not? Vanessa Dekou, CEO at Clinical Services International, identifies the key element that can help you make the right choice for your clinical trial supplier.

There are multiple articles, podcasts and the like on the importance of ‘knowing what you don’t know’, because people make bad decisions when they have incomplete information. As a comparator sourcing partner, it’s just as important that we aim to reduce what we don’t know, and consolidate what we do, into an accurate and up-to-date overview. After all, how else can we evaluate whether the solution we’re offering a client is a worthwhile investment for them?

You’re only as strong as your data

Data collection is vital to serving our clients well, and behind every two-line confirmation email saying “Yes, we can help” is an army of researchers working away to find the most comprehensive solution to each of our clients’ comparator sourcing problems. One of the challenges of global comparator sourcing is ensuring that our understanding remains up to date. Last quarter’s preferred supplier for a particular drug in a given country may not be offering the best deal this quarter. It takes time, energy and a commitment to research to ensure that data remains useful; if it is inaccurate or misleading, it can waste valuable time or, worst of all, fail to help us secure the very best solution for our clients. And that is something we simply cannot accept.

“Behind every two-line confirmation email is an army of researchers working away to find the most comprehensive solution to our client’s comparator sourcing problem.”

Data in, data out

Solving a client’s problem requires a thorough understanding of what we are dealing with; as the old adage goes, ‘garbage in, garbage out.’ Without knowing the scope of a clinical trial and nailing down the details – comparators, timelines, quantities, etc. – it’s almost impossible to develop a comprehensive solution, even with an excellent global network of suppliers and manufacturers. We’re also keen to fully understand a client’s key concerns, so that we can offer alternative packages to suit their needs. For example, a more expensive product may be available within a shorter time frame than a cheaper alternative, and our client can make the final call as to whether time or money is the priority. 

Map the market

Before responding to a client’s request, we need to ‘map the market’ and undertake extensive research to understand global comparator availability, quantity, cost, import and export regulations, and logistics – there’s an awful lot to consider! 

Mapping the market

For example, it might be that a supplier in a small market such as Greece or Bulgaria can offer the lowest price, but simply cannot offer the quantity required for a large clinical trial. In addition, it’s important to have a handle on the product usage per country to forecast potential disruptions in comparator supply.

“The goal is to turn data into information, and information into insight.” Carly Fiorina, former CEO at Hewlett-Packard

Data drives a better deal

In everyday life, we are used to shopping around for a better deal rather than going with the first item we find, and we don’t expect a product’s price to increase for no discernible reason. Knowledge is power, and the same holds for comparator sourcing. Keeping track of price hikes and reductions, and alternative suppliers often enables us to negotiate a better deal for our clients, or walk away from an offer that on reflection is not as promising as it first seems. Reliable data enables us to determine what a ‘good deal’ really looks like. 

Data delivers better service to all clients, big and small

At CSI, we’re proud to stand by our belief that all our clients deserve the very best service, whether they are sourcing comparators worth thousands, or hundreds of thousands, of pounds. Delivering this kind of service is made much easier when we can draw on an extensive database, and offer an overview of drug pricing, quantities, suppliers, etc. across the world. Rather than starting from scratch each time, we can simply build on our existing knowledge and connections, with each new project refining and contributing to our overall understanding of the global market and supply chains.

Data-driven solutions that you can rely on

Since our founding, CSI has recognised the value of data in delivering excellent service and value for money. Our ongoing research and methodical approach to capturing and organising data allows us to truly evaluate and identify the ideal comparator sourcing package for our clients. So, when it comes to choosing your next partner, why not ask the following simple question: 

“How do you know that you are offering us the best solution?”

If the answer doesn’t mention extensive data collection, management and ongoing research, then it’s time to contact CSI and discover for yourself how comprehensive our service is.

Outsourcing in Clinical Trials Nordics 2018, Copenhagen, 30–31 October

Thank you to everyone who met our experts at CPhI in Madrid. Next, you can find us at Outsourcing in Clinical Trials Nordics 2018 in Copenhagen, Denmark, where we look forward to discussing your clinical trial requirements. We hope to see you there!
If you can’t make it to Copenhagen, we will also be at the Jefferies 2018 London Healthcare Conference, 14–15 November.

Forthcoming conferences: CPhI Worldwide; Outsourcing in Clinical Trials Nordics 2018; Jefferies 2018 London Healthcare Conference

Meet our experts at one of our forthcoming conferences to discuss your clinical trial requirements:
CPhI Worldwide, Madrid, 9–11 October
Outsourcing in Clinical Trials Nordics 2018, Copenhagen, 30–31 October
Jefferies 2018 London Healthcare Conference, 14–15 November
We look forward to seeing you there!
 

Clinical Operations in Oncology Trials Europe 2017, Munich, 5–6 December

Thank you to everyone who came to see us at the Jefferies 2017 London Healthcare Conference in London. Your next chance to meet our experts will be at the Clinical Operations in Oncology Trials Europe 2017, taking place in Munich on 5–6 December.

As the only operationally focused oncology conference in Europe, this two-day event is a must attend. The 2017 programme will host speakers from the likes of Takeda Oncology, Bayer Healthcare, Roche, Medigene and PsiOxus Therapeutics.
Highlights for 2017 include an interactive panel discussion debating the benefits of partnering with Patient Advocacy Groups; a member of the EORTC discussing the advantages of oncology protocol designs; and spotlight sessions exploring what to consider when conducting a global oncology trial.

We look forward to seeing you there!

Jefferies 2017 London Healthcare Conference, London, 15–16 November

Meet our experts at the Jefferies 2017 London Healthcare Conference, which will take place at the Waldorf Hilton, Aldwych, London WC2B 4DD, 15–16 November.

Now in its eighth year, the Jefferies Conference is the largest healthcare-dedicated conference in Europe. This year, we hosted 350 participating companies, 1,400 attendees and 3,400 investor and business-to-business meetings. The event featured leading public and private companies from the pharmaceuticals, biotechnology, generics, consumer health, animal health, medical technology and healthcare services sectors from the United States, Europe, Africa, Middle East, Latin America, Russia, India, Israel, China and Japan.

We look forward to seeing you there!