English Dutch French German Hindi Italian Japanese Portuguese Russian Spanish

Project Management Tools

Written by Anayansi Van Der Berg.

Our consultants are Certified Project Managers (PMP) and members of the Project Management Institute (PMI) – http://www.pmi.org

RA eClinical Solutions adopted EASY PROJECTS.NET as our primary project management tool.  EP.NET is a web application for managing and tracking tasks and projects.

Each client is assigned a ‘customer account’ that can be accessed anytime 24x7 from any computer connected to the internet.

Benefits:

    • Up-to-date project information is available to team members online in real-time
    • Project members can share files and notes
    • Email notifications keep project members updated  with recent information in real-time
    • Message boards provide the whole team, including the customer, with an opportunity to discuss any task or issue and keep a log of that discussion
    • More accurate customer quotations and billing
    • For customers that prefer Microsoft Project, we have a client/server application available, if needed.


PMP® Certification Exam Prep (contact us for more details)

 


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.

Project Plan: CDISC Implementation

Written by Super User.

CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research - Project Management.

As with many projects, CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a 'Position Statement'.

So what is CDISC? We can say that it is way of naming convention for XPT files, or field names naming conventions or rules for handling unusual data. Currently, there are two main components of CDISC: SDTM (Study Data Tabulation Model) and aDAM (Analysis Data Model).

As a project manager and with the right tool, you can look to a single source project information to manage the project through its life-cycle - from planning, through execution, to completion.

1)Define Scope: This is where you're tested on everything that has to do with getting a project up and running: what's in the charter, developing the preliminary scope, understanding what your stakeholders need, and how your organization handles projects.

The scope document is a form of a requirement document which will help you identify the goals for this project. It can also be used as a communication method to other managers and team members to set the appropriate level of expectations.

The project scope management plan is a really important tool in your project. You need to make sure that what you're delivering matches what you wrote down in the scope statement.

2)Define Tasks: we now need to document all the tasks that are required in implementing and transforming your data to CDISC.

 

Project Tasks  (Work packages)Estimates (work unit)
Initial data standards review 27
Data Integrity review 17
Create transformation models 35

The work breakdown structure (wbs) provides the foundation for defining work as it relates to project objectives. The scope of work in terms of deliverables and to facilitate communication between the project manager and stakeholders throughout the life of the project. Hence, even though, preliminary at first, it is a key input to other project management processes and deliverables.

3)Project Plan: Once we completed the initiation phase (preliminary estimates), we need to create a project plan assigning resources to project and schedule those tasks. Project schedules can be presented in many ways, including simple lists, bar charts with dates, and network logic diagrams with dates, to name just a few. A sample of the project plan is shown below:


4)Validation Step: Remember 21 CFR Part 11 compliance for Computer Systems Validation? The risk management effort is not a one-time activity on the project. Uncertainty is directly associated with the change being produced by a project. The following lists some of the tasks that are performed as it pertains to validation.

  • Risk Assessment: Different organizations have different approaches towards validation of programs. This is partly due to varying interpretations of the regulations and also due to how different managers and organizations function. Assess the level of validation that needs to take place.
  • Test Plan: In accordance with the project plan and, if not, to determine how to address any deviation. Test planning is essential in: ensuring testing identifies and reveals as many errors as possible and to acceptable levels of quality.

  • Summary Results: This is all the findings documented during testing.

An effective risk management process involves first identifying and defining risk factors that could affect the various stages of the CDISC implementation process as well as specific aspects of the project.

Clinical Staffing and Resourcing

Written by Anayansi Van Der Berg.

We focus on providing staffing solutions across multiple areas of clinical research and development in areas of the pharmaceutical, biotechnology and medical device industries, including:

RA eClinical Staffing Solutions

Our Consultants have extensive exposure to:

  • Clinical Data Management
  • EDC Programmers, Database Programmers and Project Developers
  • Biostatistics and SAS Programming
  • Regulatory, Safety and Medical Writing
  • Project Management
  • Oracle Developers/DBAs

How We Work

Contingent
A traditional pricing model in which RA eClinical Solutions receives a fee only after successfully placing a candidate.

Contract
An hourly-based fee is agreed upon and paid to RA eClinical Solutions for short-term and contract placements.


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.

Joint Effort: Cooking Workshop

Written by Anayansi Van Der Berg.

During the delicious Tai, Korean and Vietnamese Cooking workshop we learned some secret tips and tricks from the master chef as well as experimented with new cooking techniques. A fun way to eat in a relaxed setting and taste your colleagues creations!

Thai Gren Curry with Tofu
 

This dish was very easy to make. If you are not careful, or if you don't like hot peppers, then this dish might just be too hot.

We used tofu (as vegetarian replacement for meat) but you can make it with chicken, veggie chicken or pork. Serve tofu over the rice...

Izda: Thai Green Curry (Tofu with coconut oil, ginger, baby basil, 17 red and green peppers. Hot peppers! )

We believe spending time outside the regular work environment is key to improving our relationships not only with our colleagues but with our clients.

      Some benefits to this type of event:
  • Loyalty to our customers and employees
  • Unforgettable experiences
  • Building long-term relationships with our customers
  • New business development

This activity is jointly hosted by RA eClinica and RA Foundation, which provides support services to the community. For more information about non-profit events organized by this organization, click here!

No images

QUICK CONTACT