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SOLVING DATA COLLECTION CHALLENGES

Written by Super User.

Data Collection Challenges

Cross-partnership between sponsors and CROs for the collection and analysis of clinical trial data are complex. As a result there are a number of issues encountered during the running of trial.

As with many projects, standardization projects like CDISC is a huge undertake. It requires resources, technology and knowledge-transfer. The industry (FDA for example) has been working on standardization for years but on September 2013, it became official, in which the FDA released a 'Position Statement'.


Data Collection

According to the WHO, data collection is defined as the ongoing systematic collection, analysis, and interpretation of health data necessary for designing, implementing, and evaluating public health prevention programs.

Sources of data: primarily case report books or (e)CRF forms, laboratory data and patient report data or diaries.


Challenges of data collection

It is important for the CROs / service providers to be aware of the potential challenges they may face when using different data collection methods for partnership clinical studies. Having several clients does not mean having several standards or naming conventions. This is the main reason why CDISC is here. So why are many CROs or service providers not using CDISC standards?

Another challenge is time limitations. Some clinical trials run for just a few weeks / months.

It may be found difficult to understand the partnership in the amount of time they have. Hence, most CROs and service providers prefer to perform manual mapping at the end of the trial, hence, re-work and manual work.

Funding also plays a key challenge for CDISC-compliance data collection study. Small researchers or biotechnology companies that do not have the resources in-house, out-sourced this task to CROs or service providers and are not interested whether it is compliance as long as it is save them money. But would it save money now instead of later in the close-out phase?

If there is a shortage of funding this may not allow the CRO or service provider all the opportunities that would assist them in capturing the information they need as per CDISC standards.

We really don't have the level of expertise or the person dedicated to this that would bring, you know, the whole thing to fruition on the scale in which it's envisioned - Researcher


Role of the Library

There is a clear need for libraries (GL) to move beyond passively providing technology to embrace the changes within the industry. The librarian functions as one of the most important of medical educators. This role is frequently unrecognized, and for that reason, too little attention is given to this role. There has been too little attention paid to the research role that should be played by the librarian. With the development of new methods of information storage and dissemination, it is imperative that the persons primarily responsible for this function should be actively engaged in research. We have little information at the present time as to the relative effectiveness of these various media. We need research in this area. Librarians should assume an active role in incorporating into their area of responsibility the various types of storage media. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC232677/]


Review and Revise

At the review and revise stage it might be useful for the CRO or service provider to consider what the main issues are when collecting and organizing the data on the study. Some of these issues include: ensuring sponsors, partners and key stakeholders were engaged in the scoping phase and defining its purpose; the objectives have been considered; the appropriate data collection methods have been used; the data has been verified through the use of multiple sources and that sponsors have approved the data that is used in the final clinical data report.

Current data management systems must be fundamentally improved so that they can meet the capacity demand for secure storage and transmission of research data. And while there can be no definitive tools and guideline, it is certain that we must start using CDISC-standards from the data collection step to avoid re-inventing the wheel each time a new sponsor or clinical researcher ask you to run their clinical trial.


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.

Why Work at RA eClinica?

Written by Anayansi Van Der Berg.

The clinical research environment is fast paced and offers the novice programmer the opportunity for acquiring pharmaceutical experience in different therapeutic areas. An employee or consultant who shows talent, motivation, and productivity in this arena will have a strong basis to continue a consulting career in our company.

We offer flexibility in format and scheduling than working for a corporate office. Our flextime, means anytime, anywhere as long as you participate in clients meetings, respond to emails or client's request and meet deadlines.

For those who prefer a technical career track, we provide greater advancement potential than the traditional corporation, since our main focus is our 'technical services'.

Who are RA eClinica Staff?

We offer opportunities to a diverse group of potential members to our 'employee-owned' philosophy. A graduate with only academic background may start as a apprentice or intern to gain invaluable pharmaceutical and technical experience.

We have consultants with several years "contracting" experience under our belt whose main product is our 'consulting skills'.

with Globalization an important trend in the modern pharmaceutical and biotechnology industry, and companies located in the United States and Europe wishing to gain regulatory approval companies for sale of their products in other countries, our well-positioned offices abroad further the global aspirations of the major pharmaceutical players.

So whether do you want to be On-Site, Off-Site, or at a Home Office, we have a place for you!

      • Our certified Medidata Rave consultants and trained InForm staff will be able to provide and support EDC development from project planning through database lock whether on-site or offsite.
        Not only we can provide training but we are committed to delivering quality service to your organization or CDM department.

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.

CDISC/CDASH Standards at your Fingertips

Written by Super User.

CDSIC/CDASH

A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials.

There are some defiance in implementing CDISC in EDC CDMS:

1. Key personnel in companies must be committed to implementing the CDISC/CDASH standards.

2. There is an initial cost for deployment of new technology: SDTM Data Translation Software, Data Storage and Hosting, Data Distribution and Reporting Software.

3. It can be difficult to understand and interpret complex SDTM Metadata concepts and the different implementation guides.

4. Deciding at what point in a study to apply the standards can be challenging: in the study design process, during data collection within the CDMS [CDASH via EDC tools], in SAS prior to report generation [ADaM], or after study completion prior to submission [SDTM].

5. Data management staff [CDM, clinical programmers], biostatisticians, and clinical monitors may find it difficult to converge on a new standard when designing standard libraries and processes.

6. Implementing new standards involves reorganizing the operations of (an organization) so as to improve efficiency [processes and SOPs].

7. Members of Data Management team must be retrained on the use of new software and CDISC/CDASH standards.

8. There are technical obstacles related to implementation in several EDC systems, including 8 character limitations [SAS] on numerous variables, determining when to use supplemental qualifiers versus creating new domains, and creating vertical data structure.

Anayansi Van Der Berg is a gold member of the CDISC organization providing support to CFAST projects. She is available for consulting projects.

Where Clinical Research meets Technology

Written by Anayansi Van Der Berg.

We are a specialty company with a focus on Information Technology, Pharmaceutical, Biotech, and Contract Research Organizations. More specifically, we specialize in those areas surrounding EDC and CDMS Validated Systems, Clinical Research, Clinical Data Management and Clinical Data professionals of all levels.

We provide Consultancy or Direct Hire Services in accordance with our client needs.
We have a staff of experienced recruiting specialists who bring with them an in-depth network and rely on maintaining contact with industry professionals in order to fill our client’s needs.

Why work with RA eClinical Solutions:

  • We understand the unique challenges of our industry
  • We recruit at a world-wide level and work with a select group of professionals
  • Quality and integrity is our business model

Service Offerings:

  • Clinical Data Professionals / Data Managers
  • Clinical Project Managers
  • SAS Programmers, Bio-Statisticians
  • IT Systems Professionals, Application Developers

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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