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.

Advertisements

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.

 

 

5 Ways Academic Research Organizations Can Cut Clinical Trial Costs

HealthcareAcademic Research Organizations (AROs) face one specific challenge in performing clinical research: strict budget requirements.  AROs usually secure funding from the institution itself, private foundations or even government funding, however with economic downturns and budget costs, AROs are finding it increasingly difficult to secure the appropriate funding for research. Many have partnered with large pharmaceutical companies to bring new drugs to market, but in this case, the university usually takes on a CRO role performing data collection and analysis activities to help the pharma companies cut costs. 

To maintain the integrity of original academic research, ARITHMOS has identified 5 potential ways to cut clinical costs implementing basic technology solutions.

  1. Go Paperless. By now, even AROs can recognize the benefits of EDC vs paper. Besides higher data quality, better patient compliance and real time results, using electronic data collection can significantly reduce costs. Those evaluating the clinical data will have access to data in real time and can make decisions that will reduce trial timelines. The financial benefit of EDC systems is that they produce an overall better Return on Investment in terms of quality and efficiency.
  2. Enlist an expert to define requirements. You’ve made the decision to go paperless, now consult a technology/EDC expert to define user requirements for your organization. Technology business analyst with expertise in life sciences suggest time-saving and cost-cutting measures and make sure your system is compliant with Best Practices and regulatory requirements.
  3. Select an EDC Vendor Wisely: While you’re primary concern may be budget, consider the intuitiveness and operational effectiveness of EDC systems as well as possible integration with ePRO devices. These are all requirements to define in the evaluation phase which can save costs in the long run. Lastly, be sure your EDC vendor provides technical support to prevent cost consuming errors.
  4. Join the Cloud. Consider EDC and pharmacovigilance solutions offered in cloud computing mode – or Software as a Service (SaaS). Cloud solutions can offer scalability, flexibility, self-service and pay-as-you-go options. This allows clinical researchers to pay for the functionalities needed and not pay for those not applicable to the study.
  5. Consider eLearning. Any time a new technology is implemented, training is needed for all users. Rather than factoring in travel and logistical expenses for training purposes, ask your technology provider for an eLearning solution that can be completed in-house and at the user’s pace. This will not only reduce the training budget, but will increase compliance.

ARITHMOS SOLUTION

ARITHMOS caters to the requirements of AROs by defining user requirements that meet strict budgets. As your technology provider, an expert business analyst will define user requirements and provide complete technical support.

ARITHMOS has an EDC solution specifically tailored to the needs of AROs. Symphony EDC is a simple, easy-to-use, intuitive EDC system that has the main functionality of EDC as is relatively inexpensive. This EDC platform is available as Software as a Service and is therefore customizable and with payment options that reflect the functionalities used. Training can be done by academic leaders directly to the end users.

For more information, visit http://www.arithmostech.com or http://www.symphony-edc.com.

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.

Clinical Trial Technology Guide for Biotechs

3-3-2-Cancer-Research-ABiotech companies often face challenges in product development – from finding appropriate funding to managing clinical data. Solutions like centralizing data and incorporating technology can reduce costs and improve efficiency. ARITHMOS discusses technology options for biotech companies conducting trials and preparing products for due diligence and licensing.

The European biotech picture looked bleak for a few years with a drop in funding and fewer products on the market and fewer biotech companies in the market. For example, the number of biotech companies in the UK leveled off, while products in the Phase III pipeline increased. Germany saw an increase in the number of biotechs and stagnation in the number of products on the market. In the past year, France’s biotech industry saw a funding boom and new products are entering the development pipeline.

These biotech companies increasingly need support in terms of funding and managing product development as it continues into late phases. Selecting the right technology package can be an ideal strategy.

Technology services, including EDC and ePRO solutions, pharmacovigilance applications, centralized storage and data visualization, can become part of a centralized outsourcing strategy. Using the same ePRO/EDC/IWRS reduces training and HelpDesk costs and allows for easy data integration. There would be only one set up fee for safety databases and volume discounts are applied.

How can biotech companies justify incorporating technology into their clinical trial strategy?

Centralizing data storage using a single database means there is only one database to maintain and one repository to back up. Security procedures can easily be put into place and data confidentiality is ensured, and data is easily transferable to the Sponsor via web portal containing metrics and reports. Setting up global libraries, programming macros and validation checks incur a one-time fee only. In terms of EDC, biotechs can benefit from volume discounts on licensing fees as well as pharmacovigilance database fees.

EDC Solutions: By adopting the same ePRO/EDC technology, biotechs can reduce training time and HelpDesk costs are minimized. In addition to immediate feedback and accessible trial information, EDC solutions can also increase data quality which is important for biotechs who are preparing for due diligence. EDC improves data quality by storing data in an encrypted mode, cleaning data faster with Alert and Query Manager, automated edit checks and discrepancy checks, audit trails and compliance with GCP and regulatory guidelines.

ARITHMOS EDC Solution for Biotechs: ARITHMOS has developed a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data. Symphony EDC is a reliable, cost-effective solution where a simple interface is needed.  It is a Software as a Service (SaaS) electronic data capture solution which allows users to only pay for the functionalities needed.

For more information on the appropriate technology solutions for your biotech, contact us at info@arithmostech.com

CDV1ARITHMOS is also hosting a free seminar on Wednesday, 13th of November at the University of Milan-Bicocca in Milan on Symphony and EDC solutions to meet any budget and study requirements. During this seminar, experts will demonstrate how Symphony can increase efficiency, produce higher quality data with real-time results and improve timelines all while staying within budget.