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Category Archives: Clinical Data Management

FREELANCER / CONSULTANT / EDC DEVELOPER / CLINICAL PROGRAMMER

  • Setting up a project in EDC (Oracle InForm, Medidata Rave, OpenClinica, OCRDC)
  • Creation of electronic case report forms (eCRFs)
  • Validation of programs, edit checks
  • Write validation test scripts
  • Execute validation test scripts
  • Write custom functions
  • Implement study build best practices
  • Knowledge of the process of clinical trials and the CDISC data structure

 

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ESTIMATE AT COMPLETION (EAC)

Project management is a continuous loop of planning what to do, checking on progress, comparing progress to plan, taking corrective action if needed, and re-planning. The fundamental items to plan, monitor, and control are timecost, and performance so that the project stays on schedule, does not exceed its budget, and meets its specifications.  Of course all of these activities are based on having an agreed upon Work Breakdown Structure (tasks/activities) on which to base the schedule and cost estimates.  During the planning phase of a project, the project manager with the assistance of the project team needs to define the process and procedures that will be used during the implementation phase to monitor and control the project’s performance.

Productivity in the pharmaceutical/biotech/medical device industry is going down. Some compounds have reached the billions expenditures cost without any guarantee that it will ever be approved or reach the market.  So how can we evaluate the performance of some of these clinical trials?

I will not go into details in the degree of project management activities managed and performed by a data manager since this can vary widely per company.  A good clinical data manager or manager of data management should be able to implement basic PM principles that will improve quality and timeliness of a clinical trial, regardless if the trial is fully outsourced (e.g. CRO performed most of the work).

You can find my article about the Role of Project Management in Clinical Data Management (2012) here for further reading.

So what is Estimate at Completion or EAC? or What is the project likely to cost?

There are several methods we could use to calculate EAC.

Let’s look at one formula. EAC =  AC (Actual Cost) + ETC (Estimate to Complete)  so what happens when you don’t know the ETC?

We could use the following formula to derive that value: ETC = (BAC – EV) / CPI =>>>>??? So what? More formulas? How do I get BAC or EV or CPI?

Let’s look at those in more details.

 BAC =>>>Budget at Completion (how much did you
budget for the total project?)
CPI =>>> Cost Performance Index (CPI): BCWP/ACWP

EV = Earned Value

Earned Value Analysis example for a phase 1 trial (*figures in the thousands / millions = fictitious  numbers)

The final clinical trial results includes 100 subjects. The estimated cost is $20 per subject.  That results in an estimated budget of $2000 (100 x 20). During the planning, the CRO indicated that would be able to enroll 5 subjects per week.  Therefore the estimated duration of the trial is 20 weeks (100 / 5)

EV blocks: From the project plan

Estimated Budget: $2000

Estimated Schedule: 20 weeks

Planned Value (PV): at the end of the trial is $2000

Variance between planned and actual at the end of the first week:

Based on the estimated scheduled, I should have 25 subjects enrolled. At $20 per subject, the planned value at the end of the week is $500 (25 x 20)

PV = $500

At the end of the first week, the CRO reports that he has enrolled 20 subjects  and the actual cost of that study is $450. With this information we can look at schedule and cost variance.

SV = EV – PV

SV = $400 – $500 = – 100 ($100 work of subject recruitment is behind schedule).

CV = EV – AC

CV = $400 – $450 = -50 ($50 work of the project is over budget)

*negative figures means bad.

Using early results to predict later results:

Schedule Performance Index (SPI)

SPI = EV/PV

SPI = 400/500 = .80

Cost Performance Index (CPI)

CPI = EV/AC

CPI = 400/450 = .89 –> over budget or expending more

These rations can be used to estimate performance of the project to completion based on the early actual experience.

Estimate to Completion (ETC)
ETC= (PV at completion) – EV)/CPI

ETC= (2000 – 400)/CPI

ETC = (1600/.89) =$ 1798 from end of week one (after 5 days) and it will take additional $1798 to complete the study

Estimate at Completion (EAC)

EAC = AC + ETC

EAC = 450 + 1798 = $2248

If nothing changes, based on the actual results at the end of the first week, the study is estimated  to cost $2248 (rather than the planned cost of $2000) and will take 20 percent longer.

The formulas assumes that the accumulative performance reflected in the CPI is likely to continue for the duration of the project.

You do not need to memorize all of these formulas. There are plenty of tools in the industry that does the computation for you. But if you do not have it available, you can use Excel, set-up your template and plug in the numbers.

Earned Value

 

 

 

 

 

 

 

As per PMI – PMBOK definition, Cost management “…includes the processes involved in estimating, budgeting, and controlling costs so that the project can be completed within the approved budget.”   A Guide to the Project Management Body of Knowledge (PMBOK® Guide).

We have shown you, that PM tools such as Earned Value  Analysis, can be applied to clinical trials or specific work break down (WBS) activities within the data management team.

Based on the above outcome of the project performance related to the schedule, the data manager should be able to determine if she should modify the current plan or revise the original plan.

It is a perfect tool for data managers and managers of data managers and could be part of your risk based processes.

If bringing efficiency, improving data quality and significantly reducing programming time after implementing CDISC standards is on your radar screen, I’d love to chat when it’s convenient. All the best.

Anayansi Van Der Berg has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical. SAS, CDASH/SDTM (CDISC standards implementation and mapping), SAS QC checks and clinical data reporting.

Source:

A Guide to the Project Management Body of Knowledge (PMBOK® Guide).

Notes from my PM class at Keller 2007-2009

Images – Google images

FAIR USE-
“Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for “fair use” for purposes such as criticism, comment, news reporting, teaching, scholarship, and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. Non-profit, educational or personal use tips the balance in favor of fair use.”

 

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Case Study 4: A Full Data Management Solution

Case Study 4: A Full Data Management Solution

Working in a Collaborative Environment

The Scenario:

A phase II study was being managed by a CRO that had non-dedicated teams, escalating costs, with project timelines slipping on almost every deliverable.
RA eClinica Solution:

    • RA eClinica assumed responsibility for entire data management activities consisting of Data Management, Study Build / EDC Development, and Statistics and Programming.
    • RA eClinica preferred Data Management systems utilized with Sponsor’s Safety Surveillance system and Clinical Trial Management System, CTMS

Ra eClinica Results:

    • Study ongoing – All deadlines to date have been met or exceeded
    • Cost savings of approximately 35% in comparison to traditional CRO models
    • No turnover since study start

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

The company is headquarter in Panama City and representation offices with business partners in the United States, India and the European Union. For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

 

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Case Study 3: Out-of-Box Solution

Case Study 3: Out-of-Box Solution

The Scenario:

The Sponsor required a solution to effectively manage and control users (internal and external).
RA eClinica Solution:

    • RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control
    • Develop, deploy and host the clinical documentation service and provide customer support.

Ra eClinica Results:

    • Development of an electronic tool to manage the program and provide ongoing operational management support..
    • Reports are made accessible based on permission on a web browser CFR-Part 11 compliance is maintained on security and privacy of data.
    • Reports are XML-tagged for further integration with in-house systems and third party service providers,
    • Integrated Help desk support system

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.

 

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Electronic Data Capture (EDC) Future

Electronic Data Capture (EDC) Future

While EDC has been around for many years, we all acknowledge that the percentage of EDC studies has just moved into the majority. Some of the reasons for such a slow uptake include:

1) failure to understand that EDC adoption requires significant change to fundamental business processes hindering pharma from leaving “paper” processes behind;

2) thinking that studies “outsourced” to an EDC vendor means minimal change to a clinical trials organization; and

3) continued evolution of EDC tools and vendors leading to some pharma companies chasing what appears to be the newest and best solution.

One key issue arising from EDC adoption is its disruptive effect on clinical trial site staff. Now, with the majority of clinical trials using web-based EDC tools, clinical site staff are reaching a point where they say no more EDC because the volume of EDC studies severely impacts their ability to maintain source documents and use multiple EDC tools. For example, for one EDC tool, clinical site staff must take training from each sponsor using the tool which produces a huge time burden on those individuals. Broad adoption of EDC (eCRF) standards from efforts like CDISC’s CDASH initiative may alleviate some of that disruption, but clinical site process considerations are largely being ignored. Remember, those folks are critical customers for EDC.

So, there are multiple factors creating problems for EDC adoption and their common threads all point to understanding business processes inside pharma and inside clinical trial sites. Addressing those factors should help EDC move from a simple majority to larger adoption.

The huge number of purely EDC vendors presents problems for the buyer (pharma companies). Many companies are now looking to consolidate numerous vendors to a select few. Therefore, many are looking further into the future than simply choosing an EDC vendor. They may also need an IVRS vendor or perhaps help with the trial design and data monitoring. Many of the EDC vendors cannot provide this one stop shopping. There is a legitimate concern on the part of companies that an EDC vendor may not be around in a couple of years. Many have fallen by the wayside in recent years purely because they could not compete or did not address the needs of the client.

Furthermore, there is a desire for consistency. Difference clinical groups within a company can have different preferred vendors. This can compound the problem of data collection and integration. Lastly, there is the management of the collected data–who owns it, who has access, etc. Internal politics can play a big role here. Many companies (and clinical programs) may simply decide that building is better than buying.

The main problem with EDC in the pharma industry is one of business process change. For many, the technology is very sound, and replaces labor-intensive and cost-intensive historic paper-based approaches. However, the burden of labor shifts from internal data entry staff to site-specific clinical/medical staff. There is an immediate improvement in reducing the number of queries, and that improvement, along with the speed with which data is available, is where many of the benefits reside. THe cost of moving this work to the site is non-trivial.

Research companies can gain more success with EDC systems by altering the business process within their organizations. Because the data is more timely, and more accurate earlier in the process, what else can be done within the business process to leverage the investment in EDC?
EDC is not just about moving data faster, it’s about leveraging the EDC investment of optimize the process whereby new therapies are ultimately approved for use.


RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

Consultants available for study setup, including CRF design, edit checks and CDISC SDTM clinical data click here.

 
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Posted by on October 27, 2015 in Clinical Data Management, EDC

 

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RAeClinica – Clinical Staffing and Resourcing

RAeClinica – Clinical Staffing and Resourcing

RA eClinical Trial Technology, EDC, CTMS, and Technology Integration-Software Development – Web Development and Clinical Research Organization – Contract Research Organization

Source: RAeClinica – Clinical Staffing and Resourcing

 

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RAeClinica – Where Clinical Research meets Technology

eClinical Trial Technology, EDC, CTMS, and Technology Integration-Software Development – Web Development and Clinical Research Organization – Contract Research Organization

Source: RAeClinica – Where Clinical Research meets Technology

 

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