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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.

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

 

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Overview of RA eClinica (Technology Pharmaceutical Services)

Overview of RA eClinica (Technology Pharmaceutical Services)

RA eClinica Solutions (Technology Resource Organization), is your best source for customized solutions. We focus exclusively on clinical drug development in the bio-pharmaceutical industry, we addresses a highly specialized need in an extremely large and growing market with an avid demand for qualified personnel. RA eClinica combination of clinical trials development expertise with technology integration and recruiting resource, allows each of our clients to ‘custom design’ their required needs.

RA eClinica collaborate with each client to develop a solution with our experienced ‘SMEs’ of professionals. Each team is trained in a specific functional area to ensure that each of our clients’ need are met. This approach differs from the turnkey approach of Clinical Research Organizations (CRO) employment and the low value-added commodity style of general staffing / recruitment firms.

Our dedication to serving each of our staff as well as our clients, has earned us a reputation as a reliable source of opportunities in the following areas:

Clinical Programming Clinical Research Biostatistics
Clinical Data Management EDC Developers SAS Programmers
IT Professionals Data Managers Project Managers of Data Management

If you are looking for contract staff (short and long term), permanent staff, “contract to perm” employees or project team deployment, let us help you find the right candidate.

Take advantage of everything that RA eClinica Solutions has to offer you. My colleagues and I look forward to the opportunity to work with you in the near future.


Learn the basics on how to implement CDISC data standards concepts on your clinical trials from study design to FDA data analysis submission.

Need SAS programmers, CDISC Subject Matter Experts (SMEs) or a clinical programmer? We can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.

 
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Posted by on November 5, 2015 in eClinical, Information Technology

 

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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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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.

 
 

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Good Documentation Practice (GDP) for the EDC / SAS Developer

When writing programming codes for either validating the software or for validation checks, we often have to write comments to explain why we did something.

Since the FDA regulates computerized systems used in clinical trials under the authority of Title 21 the Code of Federal Regulations Part 11 (21 CFR Part 11) – see my other article about 21 CFR Part 11 here, we need to make sure our codes and programs are documented. As you have heard before, if it is not documented, it never happened. Nevertheless, there is no mandatory regulatory agency mandating to have to do this.

GDP is an expected practice”

So how much documentation is needed? We could get into endless discussions of when we should comment, what we should comment, and how much we should comment. I have had plenty of discussions about comments with people with various opinions on the subject.

Here’s a good documentation practice for a SAS code:

For more information please visit the original post at: {EDC} Developer

Need a clinical programmer, Data Programmers (Oracle/SAS/.NET) EDC Specialists (InForm, RDC, Rave)?

Contact Us!

 

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Aside
ABSTRACT
Much effort goes into the specification, development, testing and verification of programmatic edit checks to ensure that the error rate in clinical trial data is sufficiently low as to have no statistically significant effect on the overall trial results. An analysis of several thousand clinical trials, containing over 1.1 billion data values and 1.1 million edit checks, shows that the majority of edit checks (60%) have no impact on data quality; none of these 678,000 edit checks have generated a single data query or discrepancy. What can be learnt from this analysis; can we reduce the overall number of edit checks without compromising data quality; can we identify the ‘high-performing’ edit checks and improve CRF design to avoid data entry errors; are there novel methods that might achieve similar standards of data quality with less effort?

 

Edit checks are necessary to ensure data quality reaches acceptably high levels.

Since programming edit checks takes time and resources, it’s important to ensure that the effort invested maximizes the benefit and re-usability of each edit check.

 

See attached document for full article information published by:
Optimizing Data Validation by Andrew Newbigging, Medidata Solutions Worldwide, London, United Kingdom

 
 

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Complexity and effectiveness of edit checks

 

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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

 

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