12.18.17
Reducing the costs associated with clinical trials has been an area of focus across the pharmaceutical industry for a long time. The cost of running a clinical trial can be astronomical and if a compound fails in the late phases, it can be catastrophic for its sponsor company.
In recent years, there has been more and more discussion surrounding how handling clinical data more efficiently could help to reduce time scales and costly reworks during the reporting stages. Centralizing your data during a trial could also have numerous benefits in terms of data quality. Contract Pharma spoke with Daniel Chapple, chief commercial officer at Quanticate to elaborate on the main considerations when deciding how to manage and report on your clinical data.
Contract Pharma: Clinical trials are subject to stringent regulation, how important is clinical data when it comes to the success or failure of a drug candidate?
Dan Chapple: Whichever market you are operating in clinical trials are subject to stringent regulation from regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
A lot of these regulations surround how you describe and report on clinical data collected throughout a trial. Failure to demonstrate you have complied with the relevant regulatory requirements in clinical study documentation can have a serious impact on a compound progressing through clinical trial phases to commercial production. For example, during the preparation of an integrated summary the writer must compile the results of multiple studies and draw conclusions based on the data, while following the regulatory guidelines to ensure the clinical data is accurate. Of course, they must also do this in a timely manner.
Another area, and one which regulations are playing a key role, is the data standards used across trials. More and more studies are using Clinical Data Interchange Standards Consortium (CDISC) standards, which demand a higher level of mapping legacy data, and increasingly the FDA expects these standards. Clinical data is becoming more interwoven into the regulatory requirements and high quality data is fundamental to compliance.
Contract Pharma: There has been a lot of discussion surrounding how best to improve efficiency and reduce costs during clinical trials. How can the way you handle your clinical trial data have an impact on these factors?
Dan Chapple: It’s no secret that clinical trials are expensive and increasingly companies are looking for ways to improve efficiencies to drive down costs. This is a direct result of downward price pressures from governments to allow for more affordable healthcare.
During clinical trials the accuracy and quality of your data is incredibly important and ensuring both can be time consuming, particularly if there are several parties involved in the collection and storage of your clinical data. Simplifying your data network during trials, for example by using a data specialist to manage all your clinical data requirements, can help to streamline the process of quality assurance and analysis of data, which inevitably saves time and money.
Contract Pharma: What are the benefits of using a centralised data system/service?
Dan Chapple: Centralising your data systems during clinical trials can have a positive impact on the timeframes of a clinical trial, particularly when it comes to reporting to regulatory bodies. Collecting and storing your clinical data in once place, or with one company, allows for a more efficient process. Integrating data handling activities across clinical data management, biostatistics, pharmacovigilance and medical writing services allows for effective planning and communications across functions. It also means that the data is more visible meaning that the team responsible for your clinical trial data has a greater understanding of the trial as a whole.
That being said, there’s also an argument for separating your data collection, storage and analysis from the clinical operations side of your trials. This way each team will add an extra layer of quality monitoring as they audit the other team’s information.
Contract Pharma: How can companies streamline regulatory reporting using a centralised data system?
Dan Chapple: Generally speaking, if companies use a centralised data system all of the clinical trial data should be collected and stored to the same standard and in the same format, making the compilation process at the end of a trial much more streamlined. The quality of your data often improves as a result of standardising in this way too.
The nature of storing data in this way also makes it easier to spot mistakes and inaccuracies at an earlier stage.
Contract Pharma: What impact can using a centralised data system have on data security?
Dan Chapple: Entrusting one team with collecting, monitoring and analysing your data and using a centralised data system allows sponsor companies a higher level of data visibility without the need to transfer information between multiple parties. It also makes it easier to spot mistakes and allows for efficient editing from one place, making the whole process less complex and reducing the potential impact on quality.
Daniel Chapple has overall responsibility for the commercial functions within Quanticate. This includes the business development, marketing, and the contracts and proposals groups.
Daniel has over 15 years experience within the drug development field, with the past 11 years spent within the CRO and BPO sector. Prior to joining Quanticate in 2011, Daniel was European General Manager at Cognizant Technology Solutions and has also held senior commercial positions at MDS Pharma Services and ICON Clinical Research. Daniel holds a doctorate in biochemistry, microbiology & immunology from the University of London (King's College/Guy's Hospital) and is a certified Green Belt in Lean Six Sigma.
In recent years, there has been more and more discussion surrounding how handling clinical data more efficiently could help to reduce time scales and costly reworks during the reporting stages. Centralizing your data during a trial could also have numerous benefits in terms of data quality. Contract Pharma spoke with Daniel Chapple, chief commercial officer at Quanticate to elaborate on the main considerations when deciding how to manage and report on your clinical data.
Contract Pharma: Clinical trials are subject to stringent regulation, how important is clinical data when it comes to the success or failure of a drug candidate?
Dan Chapple: Whichever market you are operating in clinical trials are subject to stringent regulation from regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
A lot of these regulations surround how you describe and report on clinical data collected throughout a trial. Failure to demonstrate you have complied with the relevant regulatory requirements in clinical study documentation can have a serious impact on a compound progressing through clinical trial phases to commercial production. For example, during the preparation of an integrated summary the writer must compile the results of multiple studies and draw conclusions based on the data, while following the regulatory guidelines to ensure the clinical data is accurate. Of course, they must also do this in a timely manner.
Another area, and one which regulations are playing a key role, is the data standards used across trials. More and more studies are using Clinical Data Interchange Standards Consortium (CDISC) standards, which demand a higher level of mapping legacy data, and increasingly the FDA expects these standards. Clinical data is becoming more interwoven into the regulatory requirements and high quality data is fundamental to compliance.
Contract Pharma: There has been a lot of discussion surrounding how best to improve efficiency and reduce costs during clinical trials. How can the way you handle your clinical trial data have an impact on these factors?
Dan Chapple: It’s no secret that clinical trials are expensive and increasingly companies are looking for ways to improve efficiencies to drive down costs. This is a direct result of downward price pressures from governments to allow for more affordable healthcare.
During clinical trials the accuracy and quality of your data is incredibly important and ensuring both can be time consuming, particularly if there are several parties involved in the collection and storage of your clinical data. Simplifying your data network during trials, for example by using a data specialist to manage all your clinical data requirements, can help to streamline the process of quality assurance and analysis of data, which inevitably saves time and money.
Contract Pharma: What are the benefits of using a centralised data system/service?
Dan Chapple: Centralising your data systems during clinical trials can have a positive impact on the timeframes of a clinical trial, particularly when it comes to reporting to regulatory bodies. Collecting and storing your clinical data in once place, or with one company, allows for a more efficient process. Integrating data handling activities across clinical data management, biostatistics, pharmacovigilance and medical writing services allows for effective planning and communications across functions. It also means that the data is more visible meaning that the team responsible for your clinical trial data has a greater understanding of the trial as a whole.
That being said, there’s also an argument for separating your data collection, storage and analysis from the clinical operations side of your trials. This way each team will add an extra layer of quality monitoring as they audit the other team’s information.
Contract Pharma: How can companies streamline regulatory reporting using a centralised data system?
Dan Chapple: Generally speaking, if companies use a centralised data system all of the clinical trial data should be collected and stored to the same standard and in the same format, making the compilation process at the end of a trial much more streamlined. The quality of your data often improves as a result of standardising in this way too.
The nature of storing data in this way also makes it easier to spot mistakes and inaccuracies at an earlier stage.
Contract Pharma: What impact can using a centralised data system have on data security?
Dan Chapple: Entrusting one team with collecting, monitoring and analysing your data and using a centralised data system allows sponsor companies a higher level of data visibility without the need to transfer information between multiple parties. It also makes it easier to spot mistakes and allows for efficient editing from one place, making the whole process less complex and reducing the potential impact on quality.
Daniel Chapple has overall responsibility for the commercial functions within Quanticate. This includes the business development, marketing, and the contracts and proposals groups.
