Testing the safety and efficacy of new drugs is a costly and complex process for
pharmaceutical organizations. A clinical trial can cost more than $1 billion and
take over 10 years.
The rising cost and complexity is compromising not only the
profitability but also the feasibility of new drug discovery, as the cost burden can have
the unwanted effect of stifling research and innovation. The pharmaceutical industry
must lower these costs in order to afford bringing new life-saving drugs to the
patients that need them.
As pharmaceutical and biotech companies seek to reduce the cost and time it takes
for new drugs to reach the market, the development stage of the drug lifecycle can
become a competitive advantage. At the end of the clinical trial pipeline for potentially
life-saving drugs and devices are patients who may be desperately waiting for
treatment, especially in therapeutic areas such as oncology. Also the sooner a drug
can pass its clinical trials, the larger the revenue before its patent expires and generic
versions can be sold. Faster clinical trials are the key to first mover advantage and
can significantly impact the economics of new drugs.
However, there is no single silver bullet that will accelerate clinical trials. Fully
optimizing the clinical trials process requires practices and tools that streamline
operations, automate processes, increase visibility and improve collaboration with
sponsors, CROs, sites, regulators, and review boards.
The entire clinical ecosystem needs an overhaul and today pharmaceutical companies have access to a variety of cloud-based technologies that can radically improve the clinical trials process. Determining the best eClinical tools to speed clinical trials Sometimes it’s difficult to determine the best tool for a job, particularly when multiple technologies are developed to handle related tasks. Where do one tool’s capabilities end and another tool’s begin? Such is the case with the technologies that pharmaceutical companies can adopt to boost the productivity of clinical trials. Using eClinical systems to speed up clinical trials understanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process 2 using eClinical systems to speed clinical trials goBalto whitePaper eClinical Systems Accelerate_26 MAY 2015 The initial wave of technology tools focused on the clinical study conduct phase, after subjects were enrolled in the study. Systems that came out of this included clinical trial management systems (CTMS) as well as interactive voice response systems (IVRS) and electronic data capture (EDC) systems. Today, approximately 80 percent of sponsors and 42 percent of CROs use a CTMS.1 Many organizations have also started implementing technology for the submission and closeout phase of the trials process. The trial master file (TMF), which compiles the documents and content that chronicle the conduct of a clinical trial, have evolved from paper-based and file-share systems to electronic “filing cabinet” applications known as eTMF. One-in-five CROs is currently using an eTMF application, while about 36 percent of sponsors are doing so. CTMS and eTMF are specialized systems of critical importance, but neither looks at endto-end improvements in clinical trials, especially in the early stages of study startup. They only squeeze time cycles out of the conduct and closeout stages.
Purpose-built study startup solutions are needed to fill this void. A study startup solution is not a CTMS or eTMF; it’s the missing piece of the eClinical jigsaw that guides sponsors and CROs through clinical study startup and serves as the repository for in progress documents. eClinical tools need to be assessed as part of the overall picture of clinical study management, rather than just looking at one piece of the clinical trial jigsaw. Each of these tools—eTMF, CTMS, and study startup—plays a distinct role in optimizing the full clinical trials process. However, their individual capabilities have become muddled in a sea of similar terms commonly used to describe their differing functions. These tools perform separate functions but serve overlapping user groups. As a result, sponsors and CROs face much confusion surrounding what each system can and cannot do. In an attempt to bring some clarity to the eClinical stack, let’s dive deeper into these tools. This information is typically stored in a trial master file, or TMF, which historically was comprised of paper documents stored centrally in physical file cabinets. In an attempt to lower costs and expedite the approval processes, the FDA created regulation CFR 21 Part 11 which enables the use of electronic records, digital media, and digital signatures resulting in the birth of the eTMF. Some sponsors and CROs have considered whether they can rely solely upon an eTMF for all documents and to also obtain management information about a particular study. While eTMF systems allow study teams to exchange, review, and archive documents, they: Can’t track critical activities and milestones eTMFs are limited to document control which reflects only 20% of startup activities such as country and study-specific SSU requirements. They also don’t track non-document activities such as submissions, site visits, training, and supplies which are an important part of the IP release green light milestones.
Don’t provide sufficient project management capabilities eTMFs can’t help you forecast and optimize the resources and business processes required to get documents and other startup activities to the end state. Nor can they facilitate all relevant communications between study teams and sites. Don’t provide visibility into overall study status and bottlenecks eTMFs don’t have the complete view of startup status at the site, local, global, and portfolio levels to enable effective partner benchmarking and study team resource allocation. Without a view into all startup activities, eTMFs can’t provide the realtime study status and cycle times required to identify and proactively manage bottlenecks and keep startup activities on track. Increase audit issues eTMFs are intended to be the repository for final, approved documents (the source of truth). Using an eTMF to store draft documents, templates, and site communications “dirties up” the eTMF and leaves an organization vulnerable to having these documents exposed during an audit. Information that was abandoned and not intended to be filed can unnecessarily be exposed to regulatory inspectors. CTMS: clinical trial execution and logistics The purpose of a CTMS is to provide operational awareness to the clinical operations department to manage all aspects of the trial process. CTMS solutions were built to be all encompassing but over time the clinical trial space became too complex to model in a single system. Other functions started popping up that required purpose-built architectures. In response, CTMS solutions broke off some of these functions into modules Could the functionality of other systems, like CTMS and study startup, be built into the eTMF? goBalto_whitePaper_eClinicalSystemsAccelerate_26 MAY2015 4 using eClinical systems to speed clinical trials of a monolithic CTMS, such as the medicinal product dictionary, planning, or finance. For other functions, CTMS integrates with best of breed applications that are separate from the CTMS itself to report a bird’s eye view of the trial status. Where CTMS excels is from clinical trial execution forward, after sites are activated. CTMS helps sponsors and CROs manage large amounts of maintenance and recruitment information across a study in order to ascertain if all the sites are filing and to make go/no-go decisions in regular intervals.
The entire clinical ecosystem needs an overhaul and today pharmaceutical companies have access to a variety of cloud-based technologies that can radically improve the clinical trials process. Determining the best eClinical tools to speed clinical trials Sometimes it’s difficult to determine the best tool for a job, particularly when multiple technologies are developed to handle related tasks. Where do one tool’s capabilities end and another tool’s begin? Such is the case with the technologies that pharmaceutical companies can adopt to boost the productivity of clinical trials. Using eClinical systems to speed up clinical trials understanding the roles of eTMF, CTMS, and study startup solutions in the clinical trials process 2 using eClinical systems to speed clinical trials goBalto whitePaper eClinical Systems Accelerate_26 MAY 2015 The initial wave of technology tools focused on the clinical study conduct phase, after subjects were enrolled in the study. Systems that came out of this included clinical trial management systems (CTMS) as well as interactive voice response systems (IVRS) and electronic data capture (EDC) systems. Today, approximately 80 percent of sponsors and 42 percent of CROs use a CTMS.1 Many organizations have also started implementing technology for the submission and closeout phase of the trials process. The trial master file (TMF), which compiles the documents and content that chronicle the conduct of a clinical trial, have evolved from paper-based and file-share systems to electronic “filing cabinet” applications known as eTMF. One-in-five CROs is currently using an eTMF application, while about 36 percent of sponsors are doing so. CTMS and eTMF are specialized systems of critical importance, but neither looks at endto-end improvements in clinical trials, especially in the early stages of study startup. They only squeeze time cycles out of the conduct and closeout stages.
Purpose-built study startup solutions are needed to fill this void. A study startup solution is not a CTMS or eTMF; it’s the missing piece of the eClinical jigsaw that guides sponsors and CROs through clinical study startup and serves as the repository for in progress documents. eClinical tools need to be assessed as part of the overall picture of clinical study management, rather than just looking at one piece of the clinical trial jigsaw. Each of these tools—eTMF, CTMS, and study startup—plays a distinct role in optimizing the full clinical trials process. However, their individual capabilities have become muddled in a sea of similar terms commonly used to describe their differing functions. These tools perform separate functions but serve overlapping user groups. As a result, sponsors and CROs face much confusion surrounding what each system can and cannot do. In an attempt to bring some clarity to the eClinical stack, let’s dive deeper into these tools. This information is typically stored in a trial master file, or TMF, which historically was comprised of paper documents stored centrally in physical file cabinets. In an attempt to lower costs and expedite the approval processes, the FDA created regulation CFR 21 Part 11 which enables the use of electronic records, digital media, and digital signatures resulting in the birth of the eTMF. Some sponsors and CROs have considered whether they can rely solely upon an eTMF for all documents and to also obtain management information about a particular study. While eTMF systems allow study teams to exchange, review, and archive documents, they: Can’t track critical activities and milestones eTMFs are limited to document control which reflects only 20% of startup activities such as country and study-specific SSU requirements. They also don’t track non-document activities such as submissions, site visits, training, and supplies which are an important part of the IP release green light milestones.
Don’t provide sufficient project management capabilities eTMFs can’t help you forecast and optimize the resources and business processes required to get documents and other startup activities to the end state. Nor can they facilitate all relevant communications between study teams and sites. Don’t provide visibility into overall study status and bottlenecks eTMFs don’t have the complete view of startup status at the site, local, global, and portfolio levels to enable effective partner benchmarking and study team resource allocation. Without a view into all startup activities, eTMFs can’t provide the realtime study status and cycle times required to identify and proactively manage bottlenecks and keep startup activities on track. Increase audit issues eTMFs are intended to be the repository for final, approved documents (the source of truth). Using an eTMF to store draft documents, templates, and site communications “dirties up” the eTMF and leaves an organization vulnerable to having these documents exposed during an audit. Information that was abandoned and not intended to be filed can unnecessarily be exposed to regulatory inspectors. CTMS: clinical trial execution and logistics The purpose of a CTMS is to provide operational awareness to the clinical operations department to manage all aspects of the trial process. CTMS solutions were built to be all encompassing but over time the clinical trial space became too complex to model in a single system. Other functions started popping up that required purpose-built architectures. In response, CTMS solutions broke off some of these functions into modules Could the functionality of other systems, like CTMS and study startup, be built into the eTMF? goBalto_whitePaper_eClinicalSystemsAccelerate_26 MAY2015 4 using eClinical systems to speed clinical trials of a monolithic CTMS, such as the medicinal product dictionary, planning, or finance. For other functions, CTMS integrates with best of breed applications that are separate from the CTMS itself to report a bird’s eye view of the trial status. Where CTMS excels is from clinical trial execution forward, after sites are activated. CTMS helps sponsors and CROs manage large amounts of maintenance and recruitment information across a study in order to ascertain if all the sites are filing and to make go/no-go decisions in regular intervals.
CTMS provides project managers with a centralized source of logistical study information
and reports derived from dates and statuses fed to it from several other sources outside
the system. CTMS must interact with other eClinical tools, including EDC, finance/
payments and eTMF, in order to extract relevant information and then provide insight into
the current operational status of each trial to those managing it.
With CTMS, trial supply and logistics can be better optimized; trial managers can more
accurately allocate resources and deploy site monitoring where it is most needed.
However, because CTMS relies on outside systems for its data, it does not provide
progress and realtime performance metrics out of the box. This limits the ability of CTMS
solutions to drive extremely time-sensitive and complex parts of a clinical trial like study
startup.
Study startup: the fastest road to first patient in
Study startup is a bottleneck at the outset of clinical trials that slows drug development.
The process leading to site activation is complex.
It requires sponsors to select sites,
negotiate contracts, fund and staff the trial, gain institutional review board (IRB) approval,
obtain supplies of the drug to be tested, and comply with pre-enrollment regulations.
Most pharmaceutical companies still track these site activation tasks and documents
using email, clunky spreadsheets, shared file drives, or cumbersome homegrown
applications. With multiple parties making updates, materials get out of sync rapidly
— this makes it difficult to track the overall status of the project.
Historically the study startup process does not help companies manage SOPs,
accomplish critical milestones, meet contractual commitments, and compare sites
efficiencies, and cycle times. Overall, it is hard to activate sites on time and budget,
especially on a global basis where the laws, regulations, and hurdles that can make or
break a trial vary tremendously.
Today, pharmaceutical companies are adding study startup applications like goBalto
Activate, a new breed of e Clinical tool that places study startup requirements as the
highest priority.
These tools are purpose-built to enable sponsors, CROs, and sites
to get clinical studies started in the shortest time possible. Study startup applications
support communicating, reporting, tracking, oversight, and data management to speed
study teams through activation.
CTMS systems are intended
to manage large volumes
of study maintenance and
logistical data; however
they are not well-suited
to support realtime
performance metrics
goBalto whitePaper eClinicalSystemsAccelerate 26 MAY 2015 using eClinical systems to speed clinical trials
Time isn’t wasted assembling and discussing status updates; instead, all stakeholders
view this information in realtime using the study startup solution so they share one version
of the truth. Real time alerts help decision makers intervene immediately, or before a major
setback has occurred, instead of after the fact. This is crucial, since in conventional study
startup, intervention usually happens after an issue has occurred, when it’s too late to
proactively avoid the problem.
Speeding study startup sets the stage for efficient progress across the entire lifecycle.
Study startup applications integrate with other e Clinical systems including CTMS and
eTMF to help companies optimize the full clinical trial process.
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