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Clinical Data Management Services

Written by Super User.

Clinical Data Management Services

Data Management Support

      • Programming, testing and maintenance of databases (OpenClinica, Medidata Rave, Medrio, OCRDC, Clintrial, Oracle InForm and many more)
      • Creation of case report forms (paper CRF and EDC)
      • Creation of data management plans (eDMPs)
      • Planning and Programming of the validation checks
      • Query Management (Creation the DCFs and incorporation of the Query retrace)
      • Encoding of AEs, medical history and concomitant medications (ICD, MedDRA, ATC)
      • SAE Reconciliation
      • Quality assurance measures
      • Development of data management structures, standards (eg CDISC) and SOPs
      • Conducting training of data input and management staff
      • SAS Programming

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 partnersin 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.

THE ONLY THREE (3) [PROGRAMMING] LANGUAGES YOU SHOULD LEARN RIGHT NOW (ECLINICAL SPEAKING)

Written by Super User.

Clinical Data Management Process

On a previous article that I wrote in 2012, I mentioned 4 programming languages that you should be learning when it comes to the development of clinical trials.

Why is this important, you may ask? Clinical Trials is a method to determine if a new drug or treatment will work on disease or will it be beneficial to patients.

If you have never written a line of code in your life, you are in the right place. If you have some programming experience, but interesting in learning clinical programming, this information can be helpful.


But shouldn't I be Learning ________?

Here are the latest eClinical programming languages you should learn:

1. SAS®:Data analysis and result reporting are two major tasks to SAS®programers. Currently, SAS is offering certifications as a Clinical Trials Programmer. Some of the skills you should learned are:

  • clinical trials process
  • accessing, managing, and transforming clinical trials data
  • statistical procedures and macro programming
  • reporting clinical trials results
  • validating clinical trial data reporting

2. ODM/XML: Operational Data Modeling or ODM uses XML to build the standard data exchange models that are being developed to support the data acquisition, exchange and archiving of operational data.

3.CDISC Language: Yes. This is not just any code. This is the standard language on clinical trials and you should be learning it right now. The future is here now. The EDC code as we know it will eventually go away as more and more vendors try to adapt their systems and technologies to meet rules and regulations.

Some of the skills you should learn:

  • Annotation of variables and variable values - SDTM aCRF
  • Define XML - CDISC SDTM datasets
  • ADaM datasets - CDISC ADaM datasets

CDISC has established data standards to speed-up data review and FDA is now suggesting that soon this will become the norm. Pharmaceuticals, bio-technologies companies and many sponsors within clinical research are now better equipped to improve CDISC implementation.

Everyone should learn to code

Therefore, SAS® and XML are now cooperating. XML Engine in SAS® v9.0 is built up so one can import a wide variety of XML documentation. SAS® does what is does best - statistics, and XML does what it does best -creating report quality tables by taking advantage of the full feature set of the publishing software. This conversation can produce report-quality tables in an automated hands-off/light out process.

Standards are more than just CDISC

If you are looking for your next career in Clinical Data Management, then SAS and CDISC SDTM should land you into the right path of career development and job security.


Conclusion:

Learn the basics and advanced SAS clinical programming concepts such as reading and manipulating clinical data. Using the clinical features and basic SAS programming concepts of clinical trials, you will be able to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files that describes the domain tables for clinical submissions.

Need SAS programmers? 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.

Overview of RA eClinica (Technology Pharmaceutical Services)

Written by Super User.

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.

List of Validation Rules for SDTM Compliance

Written by Super User.

RA eClinical Solutions CDISC-CDASH-SDTM-ADaM Support

In 2014, the FDA published its first official list of validation rules for CDISC SDTM study data standards. These rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules help ensure that the data conform to the standards, while quality checks help ensure the data support meaningful analysis.

With the help of the implementation guide, which provides documentation of metadata (data about the data) for the domain datasets that includes filename, variable names, type of variables and its labels, etc.; we can then map to the CDISC Analysis Data Model (ADaM) to be able to submit to the regulatory agency. This provides a clear content, source and quality of the datasets submitted in support of the statistical analysis performed by the sponsor.


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.

Electronic Data Capture (EDC) Future

Written by Anayansi Van Der Berg.

RA eClinica - Future of EDC

While EDC has been around for many years, we all acknowledge that the percentage of EDC studies has just moved into the majority. Some of the reasons for such a slow uptake include:

1) failure to understand that EDC adoption requires significant change to fundamental business processes hindering pharma from leaving "paper" processes behind;

2) thinking that studies "outsourced" to an EDC vendor means minimal change to a clinical trials organization; and

3) continued evolution of EDC tools and vendors leading to some pharma companies chasing what appears to be the newest and best solution.

One key issue arising from EDC adoption is its disruptive effect on clinical trial site staff. Now, with the majority of clinical trials using web-based EDC tools, clinical site staff are reaching a point where they say no more EDC because the volume of EDC studies severely impacts their ability to maintain source documents and use multiple EDC tools. For example, for one EDC tool, clinical site staff must take training from each sponsor using the tool which produces a huge time burden on those individuals. Broad adoption of EDC (eCRF) standards from efforts like CDISC's CDASH initiative may alleviate some of that disruption, but clinical site process considerations are largely being ignored. Remember, those folks are critical customers for EDC.

So, there are multiple factors creating problems for EDC adoption and their common threads all point to understanding business processes inside pharma and inside clinical trial sites. Addressing those factors should help EDC move from a simple majority to larger adoption.

The huge number of purely EDC vendors presents problems for the buyer (pharma companies). Many companies are now looking to consolidate numerous vendors to a select few. Therefore, many are looking further into the future than simply choosing an EDC vendor. They may also need an IVRS vendor or perhaps help with the trial design and data monitoring. Many of the EDC vendors cannot provide this one stop shopping. There is a legitimate concern on the part of companies that an EDC vendor may not be around in a couple of years. Many have fallen by the wayside in recent years purely because they could not compete or did not address the needs of the client.

Furthermore, there is a desire for consistency. Difference clinical groups within a company can have different preferred vendors. This can compound the problem of data collection and integration. Lastly, there is the management of the collected data--who owns it, who has access, etc. Internal politics can play a big role here. Many companies (and clinical programs) may simply decide that building is better than buying.

The main problem with EDC in the pharma industry is one of business process change. For many, the technology is very sound, and replaces labor-intensive and cost-intensive historic paper-based approaches. However, the burden of labor shifts from internal data entry staff to site-specific clinical/medical staff. There is an immediate improvement in reducing the number of queries, and that improvement, along with the speed with which data is available, is where many of the benefits reside. THe cost of moving this work to the site is non-trivial.

Research companies can gain more success with EDC systems by altering the business process within their organizations. Because the data is more timely, and more accurate earlier in the process, what else can be done within the business process to leverage the investment in EDC?
EDC is not just about moving data faster, it's about leveraging the EDC investment of optimize the process whereby new therapies are ultimately approved for use.


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.

Consultants available for study setup, including CRF design, edit checks and CDISC SDTM clinical data click here.

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