5 Life Sciences Technology Strategy Considerations for 2015

  1. Have you assembled the appropriate project team to implement a life sciences application?

The nature of projects and outsourcing today is composed of complex global projects managed by virtual teams and project variance. Outsourcing strategies and project variance leads to cost variation within a budget which usually is unaccounted for. Projects involving the implementation of life sciences applications can fail for multiple reasons – however a lack of user requirements and budget mismanagement should not be any of those reasons.

A good implementation team is usually a multidisciplinary team that adopts a risk-based approach to identifying obstacles and establishing measures that will mitigate challenges and foresee the participation of the client’s key users from the first steps of system implementation.  The key users usually collaborate with the validation team in the definition of general/regulatory user requirements, but their involvement starts at the very beginning of the project. In order to include the key/business users at this stage, the IT Project Manager should include a Business Analyst in the project team.

By using this approach, key users can deepen their understanding of how the system works and if it fits their organizational structure, processes and procedures. Consider a multidisciplinary team of business analysts, project managers qualified and specific to the system being implemented and a Computer System Validation expert (see why below!).

  1. Are you leveraging cloud-based solutions for important clinical systems?

We have stated the data before: It has been estimated that cloud computing techniques could lead to a 30 percent increase in speed to trial for clinical work, resulting in up to $400 million USD in savings.

The benefits of implementing a cloud-based solution for electronic data capture are endless: no more IT infrastructure investments, better data quality and global study management, software reusability and more secure data transfers. More importantly, cloud-based systems allow access to real time data which supports better discrepancy management, faster data cleaning and ad hoc reporting.

Cloud-based SaaS systems are ideal and cost-effective for pharmacovigilance as well by implementing a system accessible through the Internet with minimal IT effort. In this scenario, the application can be deployed using the standard validation configuration and then be customized to meet customer needs. The Cloud eliminates the need for hardware and software installation and allows clinical applications to be accessed through a web browser with personal credentials, eliminating the need for IT infrastructure such as data centers.

  1. What clinical data visualization solutions so you have in place?

Modern communication technologyIs your company looking to have access to clinical data in real time? Is Risk Based Monitoring part of your upcoming clinical trial strategy? Data Visualization tools make it possible to collect clinical and safety data from multiple sources and display the data in a structured format for the study team. The analysis team has the ability to drill-down data and click-through multiple levels of details.

Perhaps the biggest benefit is the ability to see and analyze safety data metrics from multiple sources in real-time. Real-time alerting features can notify the study team when problems arise, for example when adverse events are entered. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial decisions.

Business Intelligence tools are the best technology option for Risk-Based Monitoring. They allow for data retrieval, report development from different data sources, report delivery and cloud-based technology. Web-based applications can be accessed from various devices including PC/laptops, smartphones and tablets.

  1. Are all of your systems up-to-date and in compliance with industry standards? Are they really?

As mentioned above, every successful life sciences project team should have a Computer System Validation and Risk Management expert. Computer system validation in the pharmaceutical industry is applied from discovery through to manufacturing and supply. Between 40-60% of software defects can be traced back to errors made during the requirements stage. The costs of IT quality can be an investment: from documented planning and prototyping to review and inspection and test execution. However, the costs associated with poor quality normally outweigh the costs associated with good quality.

Defect correction, including diagnosis and bug fixing, can produce enormous costs for companies. More importantly, external failure can cause huge losses for a company. Operational defects can lead to lost productivity and lost sales. On a more serious note, it can lead to a delay in a new drug approval or even regulatory fines.

Are all of your clinical systems up to date with the latest security patches? Discontinued software versions should be considered a high security risk for critical IT components and should be mitigated by upgrading to supported versions or migrating to newer solutions in other platforms.

  1. Is your company prepared for Disaster Recovery and Business Continuity?

In an increasingly technology-dependent world, is your company prepared for a power failure? Cyber attacks? Disaster Recovery and Business Continuity is crucial for life sciences companies today. Sponsors should know if their IT provider has a plan in place – after all, consider the quantifiable losses if your IT infrastructure shut down for an hour, a day or even more? Could you go on conducting “business as usual”=

A good Disaster Recovery plan starts with analyzing the risks. Once you have determined the priorities, the most important analyses will be the RPO (Recovery Point Objectives) and the RTO (Recovery Time Objectives). The RPO will establish how far back services will have to go to find recoverable data, and the RTO will determine how much time is needed for recovery. The Disaster Recovery plan must then be maintained through proper documentation and system validation.

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Cloud-Based EDC Part 1: 10 Reasons to Consider a Cloud-Based EDC System

cloud-based EDCThe pharmaceutical industry has already been using cloud computing primarily for research purposes. It has been estimated that cloud computing techniques could lead to a 30 percent increase in speed to trial for clinical work, resulting in up to $400 million USD in savings.

If the market continues to adopt EDC/ePRO technologies, paper studies and subject diaries may no longer exist in 10 years or less.

Electronic Data Capture (EDC) has been one of the technologies frequently adapted to cloud-computing for clinical research. In this two-part blog, ARITHMOS will first list 10 reasons to consider a cloud-based approach to electronic data collection, analysis and reporting. In Part two, we will discuss how to implement a cloud-based EDC system.

10 Reasons to Implement Cloud-Based EDC

1. No more hardware/software installation

According to recent industry reports on cloud computing, computer systems can cost a company up to $2 million USD plus the additional costs for experts to install and maintain these systems. The Cloud eliminates the need for hardware and software installation and allows clinical applications such as to be accessed through a web browser with personal credentials. Additionally, a cloud computing solution eliminates the need for IT infrastructure such as data centers, significantly reducing costs.

2. Pay on a Per Study or Per Functionality Basis

With no hardware/software installation or IT infrastructure investment and no need for an expert consultancy team, the Cloud allows users to pay per study, or in some cases, by functionality used. This can result in huge cost savings for companies on a tight budget.

3. Risk-Based, Remote Monitoring

It is encouraged by regulatory authorities and Cloud based EDC allows for real time data collection and immediate analysis and reporting from various devices, anywhere there is a connection.

4. Mitigate Risk

The Cloud makes it easy to collect and transfer data into one database for quick and accurate analysis. Using HTTPS connection and various security measures, companies can ensure secure and private data transfers. Avoiding hardware/software installation also means fewer technical problems to deal with as a company, and therefore the company can focus on trial conduct and not technology issues.

5. Faster Trials

Cloud-based data delivery and management is a surefire formula for speedier clinical trials and makes proof of concept testing faster and easier.

6. More Efficient Data Management and Better Data Quality

Resolve discrepancies faster and reduce time and costs with immediate feedback from patients; Data can be transferred in real time during the study and query management is accelerated.

Ensure automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.

7. Better Global Study Program Organization

Organize multi-language, global study data into a single database; this is especially beneficial to statisticians who need up-to-date study metrics in other parts of the world.

8. Convenience of Software Reusability

With the cloud, it is possible to use the same software application for various studies which is very convenient for study sponsors. Sponsors can save time and effort on training since all data will be in one database and there is only one system to learn.

Cloud-based EDC is also more convenient for an RBM approach making it easier to analyze data across different studies.

9. Reduce training time and costs

Training efforts are kept to a minimum because of high usability and the ability to implement cloud-based eLearning solutions for EDC systems. This reduces training logistical costs for companies on strict budget requirements.

cloud10. Considerable Cost Savings

All of these above-mentioned factors lead up to the main selection driver for most companies: COST. The elimination of hardware/software and the associated consultancy, quicker and more efficient trials and better management all result in considerable cost savings.

 

Related Links

ARITHMOS Cloud Implementation Services
Symphony EDC 

The Ideal EDC System for Clinical Data Managers

At ARITHMOS‘ eCRF Symposium this month, the Director of Clinical Data Management for an international CRO, gave a presentation on the ideal EDC system and what functions are necessary for successful data management. Monica Pimazzoni has over 20 years of experience in clinical data management for both large pharmaceutical companies and in the CRO environment, and she shares her opinion of the ideal EDC system.

Conducting a clinical study requires the collection of a large amount of data that can be entered, checked, confirmed and finally grouped together in a single database. These steps require significant logistical means in order to comply with the GCP (Good Clinical Practice) and regulations on the protection of people’s safety and well-being. Setting up a central database and an electronic collection via the Internet called eCRF (electronic case report forms) meets these needs by combining technology, simplicity, privacy and data security.

What are the challenges of using paper CRF?

  • Massive amount of paperwork
  • Tedious for Investigators – repetition, data transfer, consistency
  • Tedious for Monitors
  • Tedious transport and archive activities
  • Logistical issues
  • All data must be transcribed
  • Data cannot be evaluated in real-time
  • More time and effort needed for data cleaning
  • Extended timelines from LPLV to DB lock

eCRF significantly reduces the time and costs for certain stages of a clinical study. Direct and indirect costs can be reduced thanks to parallel operations during the use of a centralized database that can be accessed simultaneously by many people using the Internet. eCRF ensures:

  • Privacy and security (password login, encrypted data, secure protocol)
  • Source data collection by the users (no double entry)
  • Effective and immediate communication between participants
  • Optimization of site visits by upstream preparation
  • Significant reduction of data collection errors through input controls
  • Remote monitoring
  • Better data input quality
  • Interim analysis that can be implemented quickly with snapshots of data exports

How to choose an EDC system:

In Europe, it is a legal requirement to conduct clinical trials in accordance with the International Conference on Harmonisation’s guidelines on good clinical practice. This leads to reporting and documentation requirements that are burdensome and complicated. There is almost a complete absence of guidance from regulatory agencies about how to evaluate the many EDC systems available.

The availability of cost-effective, open source or proprietary EDC applications for individual physicians/researchers, departments and institutions has the potential to improve clinical and research activities. Since further development/customization and ownership costs are lower, Sponsors can modify and adapt EDC systems to suit their environment and workflow, thus ensuring the success of EDC implementation. User-friendly and simple interfaces, adherence to industry standard security protocols, customization and low maintenance costs are some of the major benefits.

Cost is an important, if not the most important, factor to be considered while choosing an EDC system. Although the nature of licensing and support required to maintain EDC systems are the main predictors of cost, data capture and workflow at the site of implementation also have a major influence.

Commercial EDC systems can be expensive in comparison to open source or proprietary EDC systems. It is important to evaluate the cost-benefit analysis of each EDC system and find the functions that best fit your company’s needs and budget.

What do Clinical Data Managers Want?

  • An EDC system compliant with regulatory requirements: audit trails, data validation, system integrity
  • A system that enhances communication and sharing with users
  • Flexibility to allow for study specific customizations and dynamic forms
  • Intuitiveness and user-friendly system that is easy to navigate
  • Intuitive to select visits and enter data for end users
  • Easy to retrieve data queries
  • Efficient data cleaning and easy to update
  • Easy for study monitors to perform and mark SDV
  • Easy for Investigators to sign when CRFs are complete

ARITHMOS Solution

ARITHMOS has various EDC solutions available depending on the Sponsor’s needs and budget. Sponsors can meet with one of our business and application analysts to define user requirements. ARITHMOS can also support licensing, implementation and maintenance needs for various EDC systems as well as provide ongoing support in terms of HelpDesk and eLearning.

ARITHMOS also offers a proprietary EDC system, Symphony EDC, which is an affordable system that covers the main functions for data collection and reporting and can be customized based on study needs.

To what degree does Information Technology Influence Pharma Operating Strategies?

Pharma ITThe eClinical trial technologies market is set to reach $1.37 billion USD by 2018. The driving forces behind this surge are the pharma industry’s narrowing drug pipelines, expiring patents of popular drugs and the scarcity of prospective drug launches. Therefore, there is a need in the pharma industry to find tools that can accelerate the drug development process and boost productivity. ARITHMOS explores how IT tools are influencing operational strategies in the pharma industry. 

Why are pharma companies looking to implement life science technologies? Clinical trial technologies enable real-time data analysis, cut costs while optimizing the drug development process and are utilized to make “go/no-go” decisions quicker. However, there are different needs for different market sectors such as large pharma, small to mid-size pharma (SMB), biotechs, academic and hospital research centers and CROs.

Let’s look at the similarities and differences for large pharma vs. SMB pharma; IT needs include:

  • Compliance with Regulations: adapting a risk based approach, shortening the validation effort
  • Costs: low cost/open source solutions, effective project management
  • Technology Solutions: support for technology selection, technical support and maintenance, external hosting solutions
  • Flexibility: Customization, easy-to-use clinical applications, integration with other systems/devices
  • Efficient Processes: solutions to streamline internal processes

The SMB market sector, however, faces challenges in implementing IT solutions. They often have a lack of expertise, training and finances for technology upgrades which leads to limited adoption of IT solutions. SMB, compared to large pharma, does not have economies of scale to exploit the building of informatics system solutions.

In addition, SMB companies are affected by the risks of various failure scenarios such as: creating a system they can’t afford to validate, creating a system that is unable to grow with the company, or creating a system that is too costly to maintain.

All of these factors influence how a company integrates IT into an operating strategy. The solution is to engage the support of an IT supplier which can provide:

  • Business Requirement Analysis
  • Selection of appropriate eClinical Solutions
  • Consultancy for the implementation, validation, support and maintenance of the chosen solution
  • Hosting model/SaaS
  • Integration with other applications (ePRO/EDC integration)
  • Providing customized reporting
  • End User Training (e.g. eLearning)

Let’s look at an example of this strategy put into practice. Generally, researchers don’t want to spend much time finding data management solutions or solving technology support problems. They would rather spend their time doing research.

Therefore the high level EDC business requirements would be defined as: low-cost, web-based, ease of designing CRFs including automated error detection, scalable and the availability of training materials and documentation.

Proposed Solution

Investigator PdaPharma companies, especially those in SMB category, can implement a customized EDC application. ARITHMOS has a proprietary EDC system called Symphony which works under the SaaS (software as a service) model. It is an intuitive EDC platform ideal for Investigator’s basic needs and provides customized reporting tools using SAS programming. HelpDesk is available 24/7 via an online ticketing platform or a toll free number for Investigator technical support.

A customizable life science technology solution is appropriate in this situation because the Sponsor is paying for the functionalities needed and not paying for those not applicable to the study. The Sponsor and site personnel can use the same application for different projects and reuse the application with slight modifications. Therefore, training efforts are kept to a minimum due to high usability.

Are study goals reached?

This customized EDC solution allows for published study results with a high impact factor. The study data is reliable and available in real-time. Finally, there is a reduced effort in technology on the part of Investigators and site personnel allowing them to increase time spent in clinical research activities.

For more information on customizable IT solutions or to consult with ARITHMOS on implementing IT into your clinical trial strategy, contact us at info@arithmostech.com. 

EDC Use on the Rise Despite Technology Implementation Concerns: an Overview

smart doctorThe global e-Clinical trial technology market is expected to reach $1.37 billion USD by 2018. Currently around 15% of newly initiated trials are using technology. Electronic Data Capture (EDC) is the fastest growing technology being adapted in the clinical trial environment despite concerns over efficiency. ARITHMOS discusses overcoming these concerns and why Sponsors should evaluate EDC options for their next study.

The United States and Western Europe have generally been the largest adopters of EDC technology. The U.S. eClinical trial technology market alone is growing 23% annually. The market is also shifting towards other geographical locations which can provide low cost, efficient solutions.

The main driver for adopting technology is the pressure on pharma, biotech and medical device companies to improve productivity, accelerate the drug development process and, of course, cut costs. There is an increasing number of clinical resources passing from preclinical to clinical trial phases, and study leaders need to be able to validate and analyze data in real-time in order to make crucial decisions.

Despite the numerous benefits – such as increased patient compliance, quicker data cleaning and real-time data – clinical trial leaders are still hesitant to adopt EDC technology. Many fear there is an added workload including double data entry, EDC edit check and technological implications. Clinical trial leaders believe that technical problems, such as complications with the actual system of lack of training and knowledge, can lead to time consuming activity.

The scope of EDC can also include the integration of an ePRO device. Another barrier to EDC/ePRO use has been the intuitiveness of devices used. While most people are comfortable using PCs, fax machines, scanners and email, many incorporating new devices such as smartphones and tablets can be challenging and require training and a different mindset.

Despite concerns, why should Sponsors still evaluate EDC solutions for future studies?

LearnThe availability of integrated data can enhance the overall drug development process through greater efficiency and effective decision-making. With adequate training and HelpDesk resources to provide continuous technical support, Sponsors should feel at ease implementing EDC technology. The main benefits include:

1. Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study into the eCRF. Query management is accelerated, and any inconsistencies in CRF or ePRO data can be checked in real time.

2. More Accessible Trial Information: An EDC solution can organize multi-language, global study data into a single database. Biostatisticians can receive up-to-date study metrics and statistical reports can be carried out in the short term with low risk of data blinding errors.

3. Higher Data Quality: Data is stored in an encrypted mode preventing data from being changed, deleted or modified. The data cleaning process is faster with Alert and Query Managers and edit and discrepancy checks are automated.

ARITHMOS also knows that one EDC system does not fit all studies. EDC selection can vary based on study phase, therapeutic area, patient enrollment and budget. Consult Arithmos for your next study to decide which EDC system or EDC/ePRO integration solution is best for your study.

 

Implementing Technology for New EU Requirements on Medical Devices

EUIn late September, the European Union approved legislation for a new approval system of high tech medical devices that mirror the approval process of the FDA. ARITHMOS gives a brief outline of the new proposed amendments and why Sponsors should consider implementing technology solutions in order to conduct more efficient and affordable clinical trials. 

The current medical device approval process in the EU is guided mostly by national law. A conformity assessment is performed by a notified body and the device obtains a CE marking meaning it can be sold in the European Economic Area.

The new legislation would eliminate the equivalence principle commonly used for market approval and require more sophisticated clinical trials. This means trial costs are going to increase as there will be a need to collect additional clinical data to demonstrate the efficacy and safety of a medical device. In an effort to guarantee patient safety, the EU is proposing more follow up during post-market including more post-market studies. Companies will need to prepare data in a traceable and readily available way. 

How can Sponsors use technology to counter these changes?

One characteristic of medical device trials is that there is a lot of variance and therefore protocol and study design are crucial. Device studies have many factors to consider such as small populations, site differences and unique study endpoints. Incorporating EDC solutions into medical device trials can be very beneficial. The availability of integrated data can enhance the overall development process through greater efficiency and effective decision-making. 

Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study and query management is accelerated. 

More Accessible Trial Information: An EDC solution can organize multi-language, global study data into a single database. This is especially beneficial to statisticians who need up-to-date study metrics, especially if they are applying an adaptive trial design method to the trial. 

Higher Data Quality: EDC improves the quality of data through automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.

 

ARITHMOS has a variety of EDC solutions to fit any study budget or requirements including smaller medical device studies which require a reliable, yet cost-effective solution. Contact us to discuss your EDC options.

12320709-medical-instruments-for-ent-doctor-on-whiteSponsors should also consider pharmacovigilance applications for the analysis of safety data. ARITHMOS offers two customized reporting solutions to automate signal detection and make safety data available in real-time. 

In addition to medical device legislation changes, Sponsors should also be aware of changing pharmacovigilance legislation in the EU. The Good Vigilance Practice (GVP) regulations went into effect in 2012, and more recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports. 

Pharmacovigilance Day – 12 November 2013 in Milan

For more information on pharmacovigilance technology solutions and EU regulations (or even questions on medical device trials), ARITHMOS invites you to participate in Pharmacovigilance Day taking place in Milan on 12th of November. This is a free seminar being conducted by ARITHMOS and Oracle Corporation on technology solutions to face the challenges of pharmacovigilance. More information is available here.

EDC System Usage Survey: How Experience Improves User Satisfaction

Arithmos has been conducting an open survey via social media on Electronic Data Capture use among clinical trial professionals to determine what the barriers to use are and why some clinical trial professionals prefer EDC over paper. To date, the survey has 178 respondents in over 25 countries – the majority of participants being Project Managers, Data Managers and Investigators. Here we share some of the results from the survey.

The Electronic Case Report Form (eCRF) is used to capture data on a patient via electronic entry. As opposed to a paper CRF, eCRF can be downloaded on electronic devices, record data in real time and increase patient compliance. So, why are some still hesitant to use eCRF?

survey 1

The majority of respondents are concerned about technical problems. Arithmos also learned through a previous question, that while many clinical trial professionals are comfortable using computers, many are not yet accustomed to using smartphones and tablets or other medical devices for collecting data.

Technology-based barriers can be overcome through training, HelpDesk services, local language support and data security.

The next question was “What are the advantages to using EDC? Check all the apply.”

survey

Therefore, if EDC is posing significant advantages, how can we overcome the barriers to EDC use and make a gradual shift to eClinical trials?

survey3

Therefore, we have learned that technical support, including HelpDesk IT and training support, is critical for EDC acceptance and continuous use. There is an opportunity for more eLearning training and to improve HelpDesk services.

prosconsedc

Arithmos analyzes the PROs and CONs of EDC use and how to overcome barriers to use.

 

The EDC usage survey is still available by clicking here. Feedback and comments on EDC usage is always appreciated as we continue our international survey. For more information on EDC, visit our website which includes an article on ePRO and EDC integration.