RSS

Tag Archives: consultancy

Technology Consultants

Technology Consultants

Our consultants are recognized for their experience, capabilities and knowledge. RA eClinical Solutions dedicates a Professional Project Team to your project to assure its success. Our team provides expertise in eClinical and eCDMS study design and implementation.

Our primary goal is to work in collaboration with our clients to provide systems and services that meet their business needs, while ensuring complete compliance with all applicable U.S. and International regulations and guidelines.

RA eClinical Technology Consultants

We provide expert-level services in the following areas:

  • Data Management including CRF Design and Protocol Review
  • Data Cleaning activities including report creation and SAS Listings (SAS®, Cognos and IReview/Patient Profiles)
  • Database Design and Development (OC RDC, OpenClinica, Rave, Medrio and InForm)
  • The Electronic Clinical Study Project Management Life Cycle (ePMC™) provided by our eClinical Team is a validated process covering every aspects of the project management life cycle. The process manages the various stages of the study, including: Project Initiation, Planning, Execution, Monitor / Control, and Closeout.

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.

Advertisements
 
Leave a comment

Posted by on December 8, 2015 in eClinical, EDC, Freelancers, Outsourcing, SMEs

 

Tags: , , , , , , , , , , , , , , , , , ,

RAeClinica – Software Development

RAeClinica – Software Development

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

Source: RAeClinica – Software Development

 

Tags: , , , , , , , , ,

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.

 

Tags: , , , , , , , , , , , , , , , ,

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

 

Tags: , , , , , , , , , ,

Case Study 2: Supporting the Sponsor with Database Transfer Solution

Case Study 2: Supporting the Sponsor with Database Transfer Solution

Assisting the Sponsor with Database Transfer Solution

The Scenario:

The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products.
RA eClinica Solution:

    • RA eClinica responsible for AE/SAE reporting, safety coding, NDA submission support
    • RA eClinica collaborated with the Sponsor’s safety team to develop a functional safety alliance consisting of over 10+ team members inclusive of management, safety and data management resources
    • Ra eClinica team is responsible for managing over 5+ compounds

Ra eClinica Results:

    • RA eClinica project team exceeded the timelines, completing the tasks approximately 30-days ahead of schedule
    • RA eClinica management collaborate with the Sponsor to redefine operational workflow and processes in order to increase efficiencies across several departments (Quality Control, Pharmacovigilance)

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.

 
 

Tags: , , , , , , , ,

From Non-SAS Programmer to SAS Programmer

SAS Programmers come from many different educational backgrounds. Many has started their careers as a Data Manager in a CRO environment and grew to become a SAS programmer. Others have gone to college and pursued degrees in math, statistics or computer science degree.

Do you have SAS Skills? First, you need to find out more about statistical programming desire skills and start to slowly learn what SAS programmers and statisticians do in the pharmaceutical industry. It is also important to understand the Drug Development and Regulatory process so that you have a better understanding of the industry as a whole as well as the drug approval process.

In addition, I have personally attended several workshop on Statistics for Non-statistician provided by several of my past employers/clients (GSK, Sanofi-Aventis, etc) so I could have a greater understanding of statistics role. I am personally more inclined to the EDC development than becoming a biostatistician but these are just some of the few steps you could take to grow your career as a SAS programmer.

Practice, Practice, Practice!

To begin learning how to actually program in SAS, it would be a good idea to enroll to a SAS course provided by the SAS Institute near you or via eLearning. I have taken the course SAS Programming 1: Essentials, and I would recommended. You could also join SUGI conferences and other user groups near your city/country. Seek every opportunity to help you gain further understanding on how to efficiently program in the pharmaceutical industry. It could well land you a Junior SAS programming position.

Transitioning to a SAS Programming role: Now that you have gotten your first SAS programming job, you will need to continue your professional development and attend additional training, workshops, seminars and study workgroup meetings. The SAS Institute provide a second level, more advance course Programming II: Manipulating Data with the Data Step, SAS Macro Language and SAS macro Programming Advanced topics. There are also SAS certifications courses available to help you prepare to become a SAS certified programmer.

There is a light at the end of the tunnel: Advance!

Your ongoing development will be very exciting and challenging. Continued attending SAS classes as needed and attending industry related conferences such as PharmaSUG to gain additional knowledge and insight on how to perform your job more effectively and efficiently.

As you can see, it is possible to ‘grow’ a SAS programmer from a non-programming background to an experience programmer. All of the classes, training, and projects you will work on are crucial in expanding your SAS knowledge and will allow you to have a very exciting career opportunity ahead of you.

Anayansi Gamboa 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.

 

Tags: , , , , , , , , , , ,

Data Management Plan in Clinical Trials

The preparation of the data management plan (DMP) is a simple, straightforward approach designed to promote and ensure comprehensive project planning.

This article is an extract from EDC Developer blog. Click here to read it. Data Management Plan in Clinical Trials.

RA eClinical Solutions provides clinical Data Management, Project Management and Technology Support within the Life Science community.

 

Source: EDC Developer

 

Tags: , , , , , , , , , , , , , , , , , ,

 
%d bloggers like this: