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

So what is CDISC? We can say that it is a 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 of 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.

A 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 the 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:

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.

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!

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