Thursday, January 29, 2015

ICT Article Feature | Risky Business: Strategic Collaborations Between Sponsors and CROs

In this month's edition of International Clinical Trials (ICT), CROS NT's Global Head of Business Development and Marketing, Chris Hamilton, talks about strategic outsourcing models between Sponsors and CROs. Chris addresses the risks of the strategic partnership approach and how to build an effective relationship and sustainable outsourcing model with CROs.

Strategic collaborations between sponsors and large CROs are now the norm, but trial partners risk being locked in with no room for manoeuvre - which can spell danger in this ever-changing market. Looking to a more flexible, long-term model must become more of an industry priority.

The clinical outsourcing world has always moved in cycles. Drug development companies - particularly the bigger players - shift from building large internal teams, to blending insourced staff with permanent teams, onto outsourcing projects or programmes, passing through functional outsourcing and arriving at strategic partnerships - before starting the whole process again. 

CROs and their customers need to be aware of the risks from the strategic partnership approach. On the CRO side, we have already seen evidence of shareholder dissatisfaction where predicted revenues from a partner do not meet market expectation. CROs cannot rely on only one or two partnerships because this makes them vulnerable; the problem is that, once parties agree multiple partnerships, individual sponsors need to ask: is my relationship still 'strategic'?

To read the full article from International Clinical Trials, click here.

For more information on CROS NT's outsourcing models or to submit an RFP, please visit our website at

Thursday, January 15, 2015

CROS NT Biostatisticians Co-Author Moderate Asthma Study Results in The Lancet Medical Journal

CROS NT’s Chairman, Paolo Morelli, and biostatistician, Marco Pannacci, are co-authors on a recent paper published in the The Lancet Respiratory Medicine featuring the results of a moderate asthma clinical trial sponsored by the Italian Medicines Agency (AIFA).

The full article can be found at in the Lancet’s most recent issue.

Paolo Morelli, given his statistical experience and background in clinical research, provided expert methodological input in the planning of Study Design, Protocol Writing, Sample Size Calculation and reviewing all statistical topics of the study.

Marco Pannacci worked as lead biostatistician on the study, planning and writing the Statistical Analysis Plan and Data Review Report, providing his support and his statistical view during the programming phase and performing statistical reviews of the final results. Marco collaborated with the main study Investigators, further expanding his experience and knowledge in the area of respiratory diseases.

The non-inferiority, randomized, double-blind clinical study screened a total of 1,010 patients between April 2009 and March 2012 with moderate persistent asthma and monitored whether a combination treatment administered “as needed” was as effective as regular treatment using the same maintenance and reliever therapy (SMART).

This study was unique in that “no previous study has investigated whether moderate asthmatics can be just as well controlled by a symptom-driven inhaled corticosteroid and long-acting beta2 agonist combination therapy in the absence of regular maintenance treatment”.

The data for the study were collected by clinical investigators and analyzed by CROS NT statisticians. The statistical analysis consisted of Kaplan-Meier estimates to assess the time to treatment failure and the probability of patients with no treatment failure at 1 year. Cox proportional hazards regression model was also used to analyze time to treatment failure. The proportional hazards assumption was assessed by using both the curves of log(–log[survival]) versus log of survival time and with the correlation of the scaled Schoenfeld residuals on functions of time.

The primary endpoint, which was time to first treatment failure measured after 1 year, was assessed in both the intention-to-treat and per-protocol population.

Conducting Respiratory Trials – a Look at Asthma
Asthma is one of the largest indications being researched in respiratory clinical trials given that around 300 million people suffer from some form of asthma worldwide. There is also a rising demand for prescription devices such as inhalers and nasal sprays for asthma treatment.

CROS NT has over 20 years of experience in conducting respiratory clinical trials and has performed over 100 trials in Phases I-IV resulting in over 50,000 patients managed in indications such as asthma, COPD, Pulmonary Cystic fibrosis, pneumonia and respiratory allergies. Our biostatisticians and data managers are well-experienced in projects involving the integration of electronic devices with EDC systems. Our solution of implementing a Spirometric device with an EDC system to record health measures and diary data has been fully validated and used in respiratory trials.

Tuesday, January 13, 2015

CROS NT Launches New Logo and Website as part of Rebranding Initiative

CROS NT today announced the launch of a new logo and a new website as part of its rebranding initiative to reflect the company’s position as a global, united brand.

The branding initiative comes after a year of restructuring following the acquisition of two biometrics CROs – MDSL International in the United Kingdom and Stat-Tech Services in Chapel Hill, North Carolina. These acquisitions have expanded the CROS NT brand internationally as well as adding a wealth of expert resources in biostatistics, clinical data management and medical writing to its team. As of January 2015, CROS NT is transitioning from the MDSL and Stat-Tech brands to the CROS NT brand name.

CROS NT remains focused on clinical data services – including biostatistics, statistical programming, clinical data management and medical writing – as well as accompanying technology such as ePRO, EDC, IWRS, CTMS and data visualization solutions for the pharmaceutical, biotechnology and medical device sectors.

Chris Hamilton, Global Head of Business Development & Marketing for CROS NT, said, “the rebranding initiative is an important step in the history of CROS NT as it demonstrates the growth in our company over the past few years and marks us as a global player in the CRO market. CROS NT is experiencing great progress due to continued excellent customer service and in high quality clinical data services”.

Andrew MacGarvey, CEO, added, “the new design brings our branding up to date while retaining elements of our original logo to ensure our strong heritage is still represented”.

The new website is live today at

Monday, December 15, 2014

What is the "Ideal" EDC System for a Clinical Data Manager?

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. Setting up a central database and electronic collection via the Internet called eCRF (electronic case report forms) meets these needs by combining technology, simplicity, privacy and data security.

According to a study by CenterWatch, if the market continues to adopt EDC and ePRO technologies, paper diaries will no longer exist in 10 years. Should paper diaries still be used to collect subject data in clinical trials? CROS NT's expert Clinical Data Management team discusses this issue and what the ideal EDC system is for data collection.

There are several challenges to using paper CRF:
  • Massive amount of paperwork
  • Tedious for Investigators - repetition, data transfer, consistency
  • Tedious for Monitors
  • 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.

Choosing the Ideal EDC System
Conducting studies in accordance with industry guidelines like ICH and GCP leads to reporting and documentation requirements that are burdensome and complicated. There is no real guidance from regulatory agencies on how to evaluate the many EDC systems available.

The availability of cost-effective, open source or proprietary EDC applications have the potential to improve clinical and research activities. User-friendly and simple interfaces, adherence to industry standard security protocols, customization and low maintenance costs are some of the major benefits.

Commercial EDC systems can be expensive in comparison to open source or proprietary EDC systems. It is important to evaluate and find the functions that best fit data management needs.

What do Data Managers want in an EDC System?

  • An EDC sytsem compliant with regulatory requirements: audit trails, data validation, system integrity
  • A system than 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
CROS NT can also offer a cloud-based eClinical application which is an integrated platform of EDC/ePRO/IWRS/CTMS. Combining an eClinical platform in the cloud with a centralized approach to clinical data, Sponsors can reduce set-up, training and HelpDesk costs and allow for easy data integration. A cloud-based solution allows for real-time study management access to data from mobile devices.

Monday, December 1, 2014

5 Things to Consider in a Global Data Strategy

Most clinical trials today are being conducted on a global level with vast amounts of data to collect, analyze and report. Trial strategies include collecting data from multiple sources and sites, ideally in real time so Data Managers can manage discrepancies and unusual data patterns and Biostatisticians can analyze incoming data and make critical decisions on trial progress.

Therefore, when implementing a global data strategy, what factors should Sponsors consider in order to ensure efficient project management, timely and quality data and cost-effective measures? CROS NT guides you through some considerations:

1. Which technology solutions are best for managing vast amounts of data?

The obvious solution may be to consider an EDC solution for clinical data management which can organize multi-language, global study data into a single database.. 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.

A cloud-based EDC system can eliminate the need to invest in an IT infrastructure while reducing training efforts. Cloud-based clinical applications also guarantee better data quality and data security through secure data transfer connections.

However, Sponsors should also consider eClinical platforms that include ePRO integration, CTMS and IWRS to manage all aspects of a clinical trial. It is important to note that not all EDC systems and/or eClinical applications fit all studies, so Sponsor should consult their CRO on which system is best.

2. Consider a Centralized Statistical Monitoring Approach

Centralized monitoring has been proposed as a new, more efficient approach to on-site visits. A CSM approach can be useful in detecting faulty equipment errors, negligence or fraud, protocol deviations and unexpected patterns which then identifies the sites that need further investigation. CSM has been suggested as a cheaper and more efficient alternative to on-site monitoring. Combining CSM with EDC and Clinical Data Visualization solutions can make monitoring extremely efficient and cost effective.

3. Should clinical data be centralized?

A centralized biometrics approach promises the Sponsor:
  • One relationship between the biometrics CRO and Sponsor and team continuity
  • Better integration of studies across all phases with common assessment methods and data standards
  • Uniform traceability of data
  • One set of biometrics Standard Operating Procedures
  • Centralization of study metrics and reporting
  • Cost reduction through the re-use of global libraries (savings up to 40%)
4. Building the Best, Most Efficient Project Team

The clinical data team is crucial to success and it’s important to have team continuity throughout global data projects. Sponsors should work closely with CROs to put together the best team of project managers, statisticians, data managers and medical writers. By centralizing biometrics, Sponsors can be ensured of the same biometrics team from start to finish. This is particularly important when it comes to the biostatistician who can provide insight from protocol to reporting through all phases of the development process.

Sponsors can also look to implement the Functional Service Provision model in which teams are assigned to a certain project for a fixed period of time. This allows the Sponsor to cover peaks and troughs in the workload while having a dedicated biometrics team.

5. Making Sense of Clinical Data: Biometrics Consultancy

Many challenges present themselves through the drug and device development process. Sponsors can’t be prepared for all issues that many arise: from trial design and sample size recalculation to regulatory challenges, sometimes Sponsors need help making sense of clinical data on a case-by-case basis. Having an expert biostatistician, data management expert or quality assurance professional available for consultancy can help Sponsors resolve small issues that arise during trials but have the potential to make a big impact.

Tuesday, November 11, 2014

Win-Win Approach for Clinical Trial Operations: Centralized Biometrics and Cloud Technology

The cost of bringing a new drug to market is now somewhere around $5 billion USD (according to Forbes) as the operational costs of conducting trials continue to rise. Sponsors are constantly looking for outsourcing methods that can cut costs. The centralized biometrics approach for clinical data has proven successful in the past at cutting costs - sometimes up to 40% with the use of global libraries. This strategy combined with cloud-based eClinical platforms can significantly reduce costs and timelines. As mentioned in last week's post, cloud technology solutions can speed up trials by 30%, pushing down costs by up to $400 million USD.

Centralized Biometrics

Using a centralized biometrics provider ensures a high level of importance and attention is given to clinical trial data. Efficiences include standardized data formats, uniform traceability of data, due diligence ready data sets and documentation as well as a single project manager for all data services.

Having the same biostatistician is also beneficial in order to provide expert consultancy on trial design and methodology, and/or apply methods to combine trial phases or adjust the sample size based on interim study results.

This model also provides financial benefits such as:
  • Saving up to 40% on database setup costs on second and subsequent studies when using EDC
  • Saving up to 40% on statistical programming costs for follow-on studies
  • Saving overall 30-40% on biometrics costs through the use of global libraries and standardized formats
Cloud Technology

Technology platforms such as EDC and ePRO solutions, pharmacovigilance applications, centralized storage and data visualization can be part of the centralized biometrics bundled package. It can potentially reduce setup, training and HelpDesk costs and allow for easy data integration. 

Cloud-based eClinical applications allow:
  • Negotiable expectations for clinical data entry into the application
  • Pay based on data quality 
  • Activity-based measurements as opposed to time based units of measure
  • Standard and ad-hoc reporting
  • Industry and regulatory compliant archival records
Risk Based Monitoring - Implementing Biometrics & the Cloud

Centralized Statistical Monitoring has been proposed as a new, more efficient and cost-effective approach to on-site visits. Centralized monitoring analyses are performed in a more efficient manner when data is centralized and the same biometrics study team has been collaborating since the beginning of the study.

In a CSM strategy, many discrepancies can be improved by implementing cloud-based technologies. Clinical Data Visualization and analytical business intelligence tools should be considered to query the EDC database and design reports for the main personnel involved in the trial review. This is especially important in order to aggregate data across multiple systems and even multiple studies. 

For more information on how to centralize your clinical data and implement a cloud-based eClinical platform, contact CROS NT.

Wednesday, November 5, 2014

Why Consider Cloud-Based EDC for your next Clinical Study?

The eClinical trial technologies market is set to reach $1.37 billion USD by 2018. The driving forces behind this surge are the need to optimize the drug development process through real-time data analysis and while cutting costs along the way. While various sectors such as small and large pharmaceutical companies, biotechnology companies and medical device companies have different trial needs, a strategic outsourcing approach that optimizes data collection and analysis can benefit any company in these sectors. Once you've decided on your clinical data outsourcing strategy, cloud-based technology can significantly improve the efficiency and accuracy of your next clinical study.

While CROS NT specializes in clinical data services - biostatistics, clinical data management and medical writing - its niche is the combination of biometrics services with clinical trial technology. We discuss why Sponsors should be shifting towards the cloud.

Several industry reports have estimated that the implementation of cloud computing technologies could lead to 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.

Eliminating investment in IT infrastructure and reducing training efforts
Cloud computing allows companies to significantly cut budgets by not having to invest in computer software or hardware along with IT installation. It is estimated that computer systems can cost up to $2 million USD to install plus additional maintenance fees. Cloud-based systems generally require minimal training efforts due to high usability and packaged eLearning solutions which not only cuts training costs, but also logistical training expenses.

Better quality data, more efficient trials
Cloud-based EDC systems allow for real-time data, immediate feedback and real-time data transfer for query management and faster data cleaning. In addition to better data quality, cloud-based systems allow for global, multi-center and multi-language studies to be organized in one single database. This becomes extremely efficient for statisticians studying metrics in real-time. Real-time metrics are important in a risk-based monitoring strategy when data managers are evaluating unusual data patterns and statisticians are analyzing data in order to target sites that need further investigation.

Data Security
Cloud service providers can implement security measures, including user and password protections, and HTTPS connections to ensure secure and private data transfers to meet tough data privacy laws. Most cloud providers have disaster recovery plans in place to guarantee data protection in case of power or network failure.

Reducing clinical trial costs
Quicker trials generally translate into reduced timelines and inevitably costs. An added benefit to cloud-based technology is that they are usually configurable and pay-as-you-go features. Some cloud-based EDC systems can even provide baseline technology for low budgets with add-on features. This allows Sponsors to effectively manage a study budget and allows clinical personnel to be more independent in study build and management.

CROS NT and Cloud-Based EDC
CROS NT can also offer a cloud-based eClinical application which is an integrated platform of EDC/ePRO/IWRS/CTMS. Combining an eClinical platform in the cloud with a centralized approach to clinical data, Sponsors can reduce set-up, training and HelpDesk costs and allow for easy data integration. A cloud-based solution allows for real-time study management access to data from mobile devices.