Why Project ERP is a Worthwhile Investment for CROs: Ensuring ROI

ACimageTo stay competitive, CROs need to focus on efficient project management and operational excellence. A project-based Enterprise Resource Planning (ERP) provides better organization, document management, scheduling and resource planning and communication.

However, one of the biggest challenges CROs face is when to risk on technology investments that can streamline processes while juggling limited resources and budgets that make an ERP investment seem too risky.

When it comes to selecting and implementing an ERP system, CROs are generally hesitant over particular these challenges:

Selecting an ERP system

CROs need to analyze their needs before comparing ERP systems. Basic systems will manage back office tasks and project management, but will they fully connect all your core business units including human resources, scheduling and finance? Meanwhile, larger systems may include unnecessary functions and complex processes that require additional investments in resources and training. CROs should start their ERP selection with companies that can offer a User Requirement Analysis. This crucial first step allows SMBs to define requirements that meet defined budget expectations.

Implementing an ERP System

CROs may argue that they lack the resources and technological competence to implement their ERP system which translates into needing additional outside consultancy for installation and extensive training. CROs should, first of all, keep in mind that implementation is the biggest milestone in the overall investment. ERP implementation will improve processes and efficiency in the long term, so CROs shouldn’t focus heavily on the costs of implementation but rather avoid “add-on” costs during implementation.

Lack of Resources

Once again, CROs need to see the long term benefit of the ERP system. Once administration processes are automated and departments are interconnected, employees will be able to spend less time on tedious “housekeeping” tasks and focus on client and business objectives.

Unpredictability

main_image_careersUnpredictability can hit CROs hard in that most will have dedicate most of their resources to managing unpredictability, and it can take a bigger toll on budgets and efficient project management which may affect communication with the client.

Document management and administrative tasks are streamlined and electronically archived so CROs can have a proper project audit trail and Sponsor records. Most importantly, a unified system that connects a project plan with the budget and resource scheduling and includes automatic alerting, CROs can be sure projects are on track and reduce unpredictability and better manage communication with the client should an unforeseen event occur.

ARITHMOSCENTRUM – Guaranteeing Return on Investment for CROs

A unified system allows for the sharing of information and data without needing multiple systems and reports and creates a central hub for document management and quality control. Administration costs are reduced in the intermediate to long term by integrating operations and business which requires less interaction between departments for back office tasks. More importantly, with ArithmosCentrum CROs can be up and running within a few days with no disruption to current projects. The system is entirely configurable to use your own terminology, processes and templates, and historical data can be imported during set up.

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A Strategic vs Maintenance Approach to Computer System Validation

keyboard-with-security-buttonAs mentioned in our last blog post on IT quality, the costs associated with poor quality outweigh the costs of investing in validated, quality systems. IT quality and validation deliver systems which are fit for their purpose and comply with pharmaceutical regulation requirements. This week, ARITHMOS outlines a strategic vs. maintenance approach to Computer System Validation best practices. 

First of all, Sponsors should know that computer system validation in the pharmaceutical industry is applied from discovery through to manufacturing and supply. The GxP standards – including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) – are applicable throughout the drug life cycle, and Sponsors should be asking themselves:

  • Do we have documentary evidence to prove our systems work as expected?
  • Are our systems developed, used and supported in a controlled manner?
  • Are we in compliance with 21 CFR Part 11 and/or EU Annex 11 and do we know how they differ for our drug development in Europe vs. US?
  • Have we assessed our systems in accordance with GAMP 5?
  • Are our systems validated according to industry and international standards?

Sponsors can take a strategic or maintenance approach to Computer System Validation – or even a hybrid model of strategic implementation and and continuous follow up.

The strategic approach to CSV means appropriate and expert planning, risk assessment and defining user requirements to guarantee the best approach. This includes business analysis by an expert consultant to include a gap and risk assessment, validation and mitigation plans, strategic planning and initial training.

Once a computer system is validated, it is important to maintain the system’s IT quality to avoid malfunctioning systems and to keep up-to-date on changing regulatory requirements. Risks associated with not maintaining IT quality include:

  • New vulnerabilities will no longer be collected, reported or analyzed
  • High risk of cyber attack on data integrity and data confidentiality (especially is working on a cloud-based environment)
  • Potential violation of data security laws
  • Non-compliance with industry standards

A maintenance approach to CSV would ensure technologies are safe and accurate for end users through a documented process for ensuring the system continuously does what it is designed to do. In a maintenance approach, services would include on-going project management, periodic review, change control, internal audit support and continuous training.

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ARITHMOS has a team of expert consultants who provide strategic advice on the right validation plan for your computerized system in the pharma industry. We also provide on-going project support for maintenance activities including offering a flexible pricing model: either on a case-by-case basis or a fixed fee monthly rate.

Contact ARITHMOS’ CSV experts for a pre-assessment meeting to see which approach works best for your company. Contact us at info@arithmostech.com. 

Successful Preparation for Regulatory Inspections of Computerized Systems – Part I

Why is inspection readiness so important in handling a successful regulatory inspection of a computerized system? Stefano Piccoli, Director of IT QA & Compliance Consulting Services for ARITHMOS, discusses appropriate preparation techniques in this blog series. 

auditRegulatory agencies often come to inspect your facility for reasons other than your CSV program.  However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, they are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

Furthermore, in the last decades, regulatory agency investigators have been trained by outside consultants and internally on regulatory issues regarding computer systems.

They have also been well trained on details of operations of typical key computer systems (e.g. MRP, LIMS, CDS, critical Process Control Systems, eCRF, Pharmacovigilance applications)

The result of this training is that more investigators are comfortable asking questions on this subject and they understand your systems better.

For a pharmaceutical regulatory inspection this is a crucial moment to maintain the authorization to produce in a certain market / country and to launch new products (in particular, the inspections by the FDA PAI). In this context, the preparation and readiness for inspection, including computer systems, is essential for the success of an inspection.

 What does computer inspection readiness stand for?

Computer system inspection readiness can be defined as the ability and preparedness of regulated areas to successfully host and withstand focused regulatory inspections of validated computer systems.

Why is inspection readiness important?

TILT_logo_AD_400x305Inspection readiness is a critical element in helping to prevent regulatory citations and achieving approvals of a new drug. It is a mistake to believe that just doing business correctly and meeting regulatory expectations will avoid difficulty in managing regulators. Mistakes made during an inspection can quickly create perception that you are out of control and possibly not in line with regulatory standards.

The intent of hosting the audit is not to “hide” any information from the inspectors. The intent is to ensure the correct information is supplied by the most appropriate person, in a timely manner.

There are several factors to consider when preparing for an inspection:

  • People
  • Behaviour
  • Documentation to review and prepare in advance of an audit
  • Logistical organisation

In Part I of this blog on CSV inspection readiness, I would like to start talking about the people involved. In subsequent blogs I’ll concentrate on the other factors.

The selection of the audit team for the computer systems under inspection is fundamental. It is important to select the appropriate people to be part of the inspection team in advance and keep people prepared and trained on how to handle the inspection and what behavior to have in front of the inspectors.

The following criteria should be used for the selection:

  • Competent
  • Confident
  • Credible
  • Knowledgeable
  • Honest

The following key people/roles should be selected and kept ready to present different computer systems

  • Computer validation managers. Usually they are the key speaker during inspection, as they are the more experienced and trained people on regulations about computer systems.
  • Process owners as they are using the systems according to SOPs and they are experts on the processes supported by the system. They are usually involved to explain how the system is used according to the SOPs and present user requirements and user acceptance testing.
  • System owners identified for all computer systems used at the facility/department being inspected. They are responsible to explain how the system is supported and maintained in accordance with applicable SOPs.
  • IT infrastructure representatives available to explain infrastructure processes supporting the computer system(s).

For more information on Computer System Validation processes or steps for regulatory inspection, contact us at info@arithmostech.com. ARITHMOS has supported numerous companies in the preparation of regulatory inspections in the clinical trial environment and can support with preparation and documentation.

 

 

Arithmos Prepares to be First Time Exhibitor at DIA Annual Meeting in Boston

13001-Reg-Opens-Nov_Template-Microsite-Slider-Banner-615x265Arithmos is set to exhibit for the first time at the DIA 49th Annual Meeting taking place in Boston, Massachusetts on 24-27 June. The DIA Annual Meeting is one of the pharmaceutical industry’s largest events, especially for North America. Arithmos is exhibiting at Booth #608 and is anxious to share its clinical trial technology products and services with the North American market, especially its ERP system, ArithmosCentrum.

Arithmos’ choice to invest in the DIA Annual Meeting in the United States was based on the opportunities to grow its clinical trial technology services for small-to-mid size pharmaceutical and biotechnology companies. Arithmos has a specific niche in making the conduct of clinical trials faster and more efficient for Pharmaceutical, Biotech and Medical Device companies as well as CROs. The company provides ePRO, EDC, CTMS, Pharmacovigilance, eLearning, Data Visualization and Project Governance. In addition, Arithmos services include data integration, computer system validation, hosting and 24/7 HelpDesk services.

linked_logoArithmos is particularly keen on introducing ArithmosCentrum to the American CRO market. ArithmosCentrum is an ERP software solution that manages the information flow between sales, project management, finance and resourcing. This system was developed by Arithmos with the goal of providing a project management system that incorporates other office tasks and links the project plan to proposal, budget and scheduling. ArithmosCentrum’s key feature is its automatic budget proposal which pulls all study information into one standard document which can be customized with a company’s logo and details.

Market research has demonstrated that ArithmosCentrum is a unique ERP system which meets the needs of small to mid-size CROs, and current CRO users can attest to its ability to improve project governance.

Arithmos will be giving demonstrations of ArithmosCentrum throughout the DIA show, and individual demonstrations can be scheduled upon request.

Attending the DIA Annual Meeting from Arithmos is Chief Operating Officer, Stefano Piccoli and Life Sciences Application Analyst, Gianluigi Albertini. To schedule a meeting of private demo of ArithmosCentrum, please contact us at info@arithmostech.com.

We look forward to seeing you in Boston!

Boston-Skyline-HDR-Panorama

ePRO Solutions for Diabetes Clinical Trials

2012-11-01-ScreenShot20121101at4.46.00PMApproximately 347 million people worldwide suffer from diabetes, 55.5 million in Europe alone. The increase in Type II diabetes patients stems from aging populations and dietary habits leading to obesity. More patients are being screened for and being diagnosed with diabetes since long term health complication include heart disease, kidney failure and neuropathy complications. Therefore, diabetes clinical trials have increased and the diabetes drug market has become quit desirable for some of the world’s leading pharmaceutical companies. Arithmos discusses ePRO solutions for diabetes trials.

How can clinical trial technology, more specifically ePRO, be beneficial for diabetes clinical trials?

There are numerous benefits for conducting trials using ePRO as opposed to paper due to patient compliance, immediate feedback and higher data quality. However, there are additional benefits for diabetes clinical trials included real time data access to blood glucose readings from glucometers,  real time access to episodic eDiary entries, and increased patient compliance with intuitive devices such as smartphones and tablets.

The use of ePRO for diabetes trials has been on the rise in the past decade as trials have increased to improve health outcomes measures and health status among diabetes patients. ePRO devices are used for QoL questionnaires. Clinical research is being driven by a search for minimally or non-invasive products for testing blood glucose levels rather than pricking the skin. Pharmaceutical companies are also looking for more cost-effective solutions. The FDA estimates that most clinical trials get delayed by up to one month, and it is estimated that for each day a trial is delayed it costs the Sponsor $8 million USD.

ePRO solutions for data collection can increase patient compliance, increase the speed with which data is collected and analyze data in real time.

There are a few noteworthy EDC/ePRO integration solutions that would specifically benefit diabetes clinical trials. Integrating an intuitive ePRO device with a glucose meter can electronically capture and deliver blood glucose levels for analysis. Two intuitive devices are the Apple iPad/iPhone and the Blackberry.

diab

With the iPhone/iPad patients are identified with a user ID and password. Data is securely transferred and does not remain on the device. Communication is encrypted and data protection is ensured.

The Blackberry Torch or Curve can be used to collect data or diary/questionnaire information. Patients are identified with a 7 digit pin number which can demonstrate evidence of patient compliance. Like the iPhone/iPad, data is transferred securely and communication is encrypted.

Arithmos has extensive experience in ePRO/EDC integration and has conducted previous studies using the iPad (for QoL questionnaires) and the Blackberry for data collection.