Why Academic Research Should Consider EDC Solutions

designer_genes_featureAcademic Research – including studies conducted by academic institutions such as universities, non-profit organizations or research hospitals – typically faces several challenges when conducting studies. The percentage of trials conducted in an academic setting is actually decreasing. These institutions often struggle to find funding and lack the support of physicians. Those conducting academic research trials usually must design the trial themselves and procure the necessary resources. Arithmos discusses EDC for the academic setting.

Electronic Data Capture (EDC) could be one solution to facilitate the conduct of clinical trials in academic or non-profit settings. The availability of integrated data can enhance the overall drug development or enhancement process through greater efficiency and effective decision-making.

How can EDC be beneficial for academic research centers?

1. Cost and Budget

EDC is generally quicker and more cost-effective than paper-based studies. While academic centers are strapped for cash, there are EDC systems that are low-cost, yet efficient. Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Query management is accelerated, and technology experts can integrate using good practice designs to support data transfers in real-time.

2. More Accessible Trial Information

An EDC solution can organize multi-centre study data into a single database. This provides biostatisticians with up-to-date study metrics and statistical reports can be carried out in the short term with a low risk of error.

3. Higher Data Quality

Academic Research Centers can accelerate approval and review timelines by improving data quality. EDC can improve the quality of data by storing data in an encrypted mode and providing audit trails. EDC systesm also provide automated edit checks and discrepancy checks, and most systems are compliant with GCP and regulatory guidelines.

symphony

Arithmos Introduces Symphony: A low-cost EDC system ideal for the Academic Community

Arithmos can offer an EDC platform that is simple and inexpensive, yet effectively manages clinical trials and collects patient data electronically. The key features of this platform include:

  • Electronic Data Collection from Investigator Sites
  • Direct patient input to web data collection
  • Easy study database build
  • Audit trail
  • Easy view of eCRF structure and status
  • Query Management

Additionally, the primary functions of Symphony are its quick and easy study build, classic project management tools, real time reporting and a public trial space to publish information and documents with a wider global audience.

Arithmos has now launched the Symphony EDC User Group Forum on LinkedIn in order to openly discuss the benefits of Symphony as well as address any issues with the system. We invite you to join the discussion

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Clinical Data Visualization and Return on Investment

CDV1One of the biggest challenges of any clinical trial is sorting and managing the vast amount of data collected. Data Visualization is the concept that data can be structured and viewed through a variety of charts and graphs to facilitate analysis. Sponsors of clinical trials needs to be able to make sense of data collected in order to make important decisions. Data Visualization is becoming increasingly important as the European Union’s data transparency policy inches closer to a reality. If clinical trial data becomes accessible to the public, pharmaceutical companies will need traceable and accurate clinical trial data.

Arithmos discusses the return on investment for implementing clinical data visualization tools. 

The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze data immediately and using data to identify and fix problems. 

Data Visualization tools now make it possible to collect data from multiple sources, even disparate databases, and display the data in a structured format for all members of the clinical team. An added value is the ability to drill-down data and click-through multiple levels of details to aid in analysis. The tools available today for data visualization are generally cloud-based which means Sponsors avoid the technology hassle of HTML or plug-ins and enjoy the convenience of data “on the go”. 

Perhaps the biggest benefit to data visualization tools is the ability to see and analyze data clinical metrics from multiple sources in real-time. Ad hoc reporting tools make metrics like site information, safety and efficacy, drug supply and patient management readily available. And if problems arise at a particular site, such as adverse events or resupply, the Sponsor can be notified immediately. 

What solutions are available for clinical data visualization?

Arithmos can facilitate the selection of data visualization tools by offering a variety of solutions for managing clinical trial metrics.

  • Arithmos has partnered with some of the best business intelligence and data visualization providers to bring “next generation” clinical data visualization tool. This tool allows Sponsors to benchmark studies and track progress as well as understand Key Performance Indicators. Perhaps the best data visualization solution in the industry, data is pulled from multiple, disparate sources and always traceable and accessible.
  • Need a solution that is compatible with a smartphone or tablet such as the iPhone or iPad? Arithmos can integrate Business Intelligence tools with Data Visualization tools on your handheld device.
  • With the changing pharmacovigilance legislation, real time safety data is crucial. Arithmos has data visualization solutions for clinical safety reporting from the best pharmacovigilance databases and systems.

CSV2EU Data Transparency Update: While the EMA released an official document in June, the implementation of the Data Transparency legislation is still in progress. The EMA is expected to have a final policy by 30th of November 2013 which goes into effect on the 1st of January 2014. Policymakers are still ironing out details on protecting patient confidentiality, clinical data formats and good analysis practices. Some pharmaceutical companies, like GSK, have already taken steps towards making data available by creating a system where researchers can request access to anonymized patient level data, and the validity of the request will be analyzed by an internal team.

 

5 Factors to Consider when Selecting an EDC Vendor

edcblogYou’ve made the decision to go EDC over paper. Now you must decide the appropriate EDC vendor for your study. There are many factors that influence this decision including study phase, therapeutic area and indication, patient enrollment and, of course, budget. Therefore, how should a study Sponsor make this important decision? Arithmos takes you through a small checklist of criteria to evaluate.

 

1. Budget

Before any study gets underway, a budget is determined which includes costs for technology. Determine your budget for EDC system keeping in mind that there are EDC systems which allow for a pay-as-you-go option. It’s no secret that pharmaceutical and biotech companies are looking to cut drug development costs, but this does not mean choosing the cheapest EDC system on the market.

Determining the EDC budget should be based on a cost-benefit analysis of the EDC system’s functionalities versus the study’s needs. 

2. Intuitiveness

Now that you have an idea of your budget for an EDC system, analyze how intuitive the system is. According to an Arithmos survey on EDC usage, there are several factors that would hinder the use of EDC, including:

  • Too time consuming
  • Technical problems
  • Familiarity with EDC  technology

Sponsors are going to want to choose a system with an intuitive interface and easy to use platform to minimize the risk of non-compliance by Investigators of patients or misuse during the study.

3. Operational Effectiveness

Evaluate EDC systems to make sure they have the functionalities that are vital to the success of your study:

  • Can you build your own study?
  • Are there data entry, coding and randomization features?
  • Are there Project Management tools?
  • Are there customized reporting features?
  • Are there re-usable templates and forms?
  • Is the system compatible with GCP and/or regulatory guidelines? Is there an audit trail?
  • Can the system handle multicentre, global studies? 

4. Integration with ePRO

For collecting data electronically, typically a PC was used on site for all patients. The market is now shifting towards individual, handheld devices which patients can use from home. Internet connection allows data transfer as well as doctor-patient communication. 

According to Arithmos’ survey, more clinical trial leaders would be open to EDC if it could integrate data from ePRO devices.

5. Technical Support

Find out if your EDC system has technical support – including HelpDesk services and training. Training is essential for those who will be using the system to avoid error. 

HelpDesk should be available – via telephone or Internet – in order to resolve any technical issues immediately.

Data-Network-concept31Arithmos can assist clinical trial leaders with the selection of an EDC system by working with study requirements and budget restraints. The Arithmos team is very proficient in working with EDC in terms of installation, validation and customization, including integration with other data sources. For example, we have designed simple and intuitive EDC systems using OpenClinica for post-market studies, installed and validated Oracle RDC, integrated spirometry devices with EDC, and integrated mobile phone and tablet ePRO data with eCRF. Arithmos has also developed a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data electronically. This low-cost EDC solution is accessible via a Web browser using secure log-in credentials. 

Arithmos also has an eLearning system for training EDC system users as well as a HelpDesk ticketing plaform available 24/7 and in multiple languages.

 

ArithmosCentrum and the CRO Project Manager: Managing Projects on Budget

logo onlyDelivering projects on budget and sacrificing time, quality or employee satisfaction is a paradox afflicting organizations. Effective project management can be the answer. 

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. Completing projects on budget can be achieved by managing four core domains: assumptions, your team, risk, and the “system”. Here is how ArithmosCentrum can help CRO Project Managers.

Planning and Forecasting

Effective and accurate planning is the first step towards successfully completing a project on a budget. Assumptions on units, resources, quality systems and technical requirements are often forecast by one party and left to another to deliver on. Knowledge management is a must. The planning phase also include risk management and communication planning.

AC allows the Project Manager to work directly with the Business Development Manager to learn the customer’s requests. Once a Project Plan is complete, the BDM is notified and can review costs and timelines. The Financial Officer is then automatically notified that a budget needs to be created.

Controlling and Monitoring

The Project Manager should be able to answer the following questions when it comes to study metrics and reporting:

  • What will be measured?
  • Why and how will we measure these metrics?
  • What are the results telling me about the status of this study?

AC allows the Project Manager to create custom reports and a customized dashboard to follow the study metrics important to each project.

PM

Communication

Communication is essential to collaboration and team performance. The Project Manager is the leader of any project and needs to be able to communicate with the team: BDMs, Financial Officer, Human Resources and operations.

ArithmosCentrum allows the Project Manager to communicate in an automatic way by sending alerts when certain tasks need to be completed. AC can also produce reports when projects are running off course in terms of resources, timelines or costs so the Project Manager can communicate with the right people.

Using ArithmosCentrum, the Project Manager can always be sure a project is staying on budget. The system automatically tracks resource planning and costs per unit or hourly rate, and the Project Manager is alerted when the budget is overrun.

Here are the inputs/outputs for the AC Project Management function:

Project Management (2)

 

 

 

 

 

 

 

3 Ways CRO Business Development Managers Benefit from ArithmosCentrum

linked_logoArithmosCentrum is the only ERP software solution (Enterprise Resource Planning) that can manage the information flow between sales, project management, finance and resourcing for any project-oriented service provider. In a Contract Research Organization (CRO) environment, clinical systems usually cater to operations and possibly finance, while Business Development Managers (BDM) are often left to their own CRM tools for tracking sales. This can leave the BDM, who also acts as an Account Executive, out of the loop in terms of project plans and finance. 

Here are 3 ways ArithmosCentrum facilitates the job of a BDM and improves project governance between sales and other departments.

CRM

1. ArithmosCentrum is a CRM solution that allows the sales team to track bids, proposals and contracts

Every project starts with your Business Development team and a sale. With ArithmosCentrum, the BDM can enter new requests into the system to track RFPs, budget proposals and any other documents from the client. All budget proposals are stored in ArithmosCentrum so the BDM can keep track of its client history.

Using the “New Request” form, a BDM can enter client basic information and then information regarding the study: therapeutic area, indication, phase, services required, etc. All these fields are customizable so the company can build a request form compatible with the BDM’s needs.

2. The BDM is always aligned with the Project Manager and Financial Officer

ArithmosCentrum links the BDM to all other operational departments, eliminating the need for excessive communication. Once the BDM enters a new request into the system, ArithmosCentrum automatically notifies the Project Manager that Project Plan needs to be created. The BDM can also assign a due date for the Project Plan and Budget Proposal to meet customer requirements.

Through an automatic alert system, the BDM knows when the project plan is complete, when the budget needs to be done and when the budget proposal is ready to send out. The BDM can then keep track of milestone payments and update the customer on project status without going through a Project Manager. Acting as an Account Executive, the BDM will know if a project is going off course in terms of timelines or cost.

cartoon-salesman-193266223. Automatic Budget Proposal Cuts Writing Time by 90%

Perhaps the most attractive feature to a BDM, the automatic budget proposal allows the BDM to focus on sales rather than writing a proposal.

ArithmosCentrum allows you to produce an automatic, yet highly customized, budget proposal using data entered into the system during the RFP and Project Plan stages. With the click of a button, the BDM can create a fully formatted proposal containing a cost summary, project strategy, list of assumptions, project schedule, details of the project team, payment schedule, etc.

The automatic budget proposal guarantees a professional document using your own corporate layout. It saves days of work every month and allows more time to be dedicated to sales, and less need for proposal writers.