We are often asked by clients whether or not PharPoint Research has global Clinical Data Management capabilities. Our answer is always a resounding ‘Yes.’
The industry tends to limit the definition of global Clinical Data Management (CDM) to the physical location of the service provider rather than the service provider’s ability to produce on-time, quality deliverables out of data coming in from around the world. There are times when the location of the CDM service provider can be a cost driving factor, but this is seldom the case. For instance, if a Sponsor is conducting a study in a remote part of the world where the Data Manager would need to physically visit a site and provide one-on-one training on the use of ePRO, the Clinical Database or CRF Completion, it would definitely be more cost-effective to select a service provider with resources in the same geographic vicinity. Barring this type of need, Sponsors should instead focus on selecting a global Clinical Data Management provider who can demonstrate core competencies such as quality, adaptive customer service, effective communication and timeline management. These competencies should outweigh the consideration of physical location of a CDM service provider 100% of the time.
In a global environment where time can equal money lost or saved, Sponsors and service providers alike need to rethink their approach to global Clinical Data Management by performing a cost benefit analysis.
Questions a Sponsor may want to consider are:
- What are the benefits to having a CDM service provider in the same country as the investigative sites? Do the benefits outweigh the costs?
- Are there any benefits to having yet one more provider office involved?
- If you already have a successful working relationship with a CDM service provider without offices located in the country where the clinical trial is being conducted, is it better to stick with a service provider with a proven track record and built-in efficiencies?
- What are the risks of selecting a new, less familiar service provider based on their physical location?
In the same vein, CDM service providers must ask if their tools, talents, and resources effectively support global Clinical Data Management without having offices in different parts of the world. If not, service providers may want to consider options such as opening new locations, networking with CDM service providers in other countries, and realigning infrastructure to enhance global capabilities without physical expansion.
Questions a service provider may want to consider are:
- What are the costs and benefits of each choice?
- If the decision is made to network with another service provider, how will consistency and quality to be ensured and measured?
- If expanding offices, what will be the impact on overhead costs?
- Is there enough potential work to support the new office?
- Are there cultural differences that will need to be considered?
- What tools, talents and resources are needed?
- How long will it take to implement the changes?
- What efficiencies will be recognized and how will they be passed along to clients?
Advances in Electronic Data Capture (EDC) minimize some of the concerns surrounding the physical location of a CDM service provider; however, it does not negate the aforementioned core Competencies (quality, adaptive customer service, effective communication and timeline management) and should not be relied upon as the ultimate solution for global Clinical Data Management. With over half of all clinical trials utilizing paper CRFs as the method of data capture, effective global Clinical Data Management service providers must be able to translate efficiencies gained from EDC to paper based studies.
Some points to consider are:
- Will the CRF design lend itself to Phase I through Phase III of the program or will it need to be tweaked with each study)?
- If a CRF template used by another service provider is supplied as a guide for the current trial, can efficiencies be gained?
- What tools and processes can the provider utilize to ensure that the database lock timelines for paper are as close to EDC lock timelines as possible?
- What is the most efficient way to obtain the CRFs from the site for processing?
The CDM service provider must be adaptable, forward thinking, and able to forecast and plan for contingencies. Global CDM service providers must be willing to creatively and critically look at best industry practices on an ongoing basis. Regardless of the data capture method or the location of the service provider, a client-focused approach using sound data management practices is a must.
At PharPoint Research, we are committed to offering our clients strategic solutions for effective global Clinical Data Management with a focus on timely and high quality deliverables, adaptive customer service, and effective communication.
We have partnered with Medidata Rave and Medrio to provide EDC support to our clients and we also offer paper based solutions meeting GCP, GLP and GSP requirements. Our partnerships with both Medidata Rave and Medrio allow us to design database screens independent of the EDC service provider thereby shortening start-up timelines and allowing quicker access to collect, analyze, and interpret data in ways that are important to your organization. Our EDC helpdesk is available to provide support based on a specified time-zone, language or country. Additionally, our data management trainers can provide one-on-one, Investigator Meeting, and web based training based on the needs of the project.
Our approach to global Clinical Data Management is team oriented, flexible, and customizable. We know that every client and project is unique and deserves the same level of attentiveness, quality, and customer support regardless of the size of the project. We provide our clients with full service consulting services, project management oversight, data entry, data validation and quality control, database design, study rescue services, and so much more. We can provide support for a single data management task or full data management services for your study. To find out about our global Data Management capabilities, please contact us at firstname.lastname@example.org.