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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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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

 

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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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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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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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Team Collaboration and Conflict

Team Collaboration and Conflict

Conflict is inevitable and can be positive. Sometimes the person who disagrees actually does have a better way. Conflict is a natural result of change, but to manage it properly, we must focus on the facts, not the emotions. In other words; focus on the problem, not the person.

Ineffective team collaboration is one of the primary contributors to costly rework and delivery failure in many projects. Team collaboration is about sharing knowledge and reaching consensus within the team.

‘Problem-Solving Teams: Quality Circles’. I personally never read an article related to ‘conflict and team members with Quality Circles’ but they primary goal to foster an exchange of ideas and the use of basic tools such as brainstorming, checklists and Pareto chart, etc. were very familiar to me.

First, we should understand the major sources of conflict for a project. For instance, at the beginning of a project, project priorities, administrative procedures and schedules are the main sources of conflict. Towards the middle and end of a project, schedules create the most conflict, followed by resources, and technical issues. Personality conflicts are lower of the list, as are cost.

After we have clear understanding of what are the conflict and the sources, we can work on resolving those conflicts. Confronting the problem head-on without being confrontational towards the person is the best win-win situation. We examine alternatives with an open mind, and really agree on the best solution.

Ideally we want to build a positive relationship with positive statements all along. If you include a positive statement at the same time you address the problem, focus on the issue and be specific. For example, “I know it is not your fault but I trust that as a good team player, you will be here from now on.”

anayansi gamboa conflicts

In order to smooth the progress of conflict resolution, we should obtain feedback during the meeting and status reports; stress to the team and customer how critical it is to communicate any issues during the status meetings or at least to the project manager. Provide an explanation with the updated information.

Many projects do not deliver, and get canceled before they are completed. Team collaboration issues are very often the reason why projects fail, but if the right infrastructure is available to facilitate effective knowledge sharing among the team members, conflict will be minimize.

Source: {EDC Developer}

 

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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)?

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