Geometry tells us that a three-legged stool provides the greatest stability. Three legs are always more stable, regardless of length or how even the surface is.
Srinivasa Rao Mandava, CDISC Expert, CSC
In the life sciences industry, where a large percentage of activities are outsourced, working with more than one outsourcer can create better synergies, such as improved clinical development productivity, reduced costs and lower risk, and – critically – the ability to gain knowledge and insights on regulatory developments and standards, such as CDISC data standardization. Each leg of the partnership has its own responsibilities, while contributing to the broader objective.
Perhaps the clearest example is the sponsor-contract research organization (CRO)-technology triumvirate. Such partnerships have the potential to advance new drug applications more rapidly – from discovery of products to development during clinical trials to submission of standardized data that can be easily analyzed with regards to safety and efficacy.
Such three-way partnerships between a sponsor, CRO and technology vendor need commitment from all parties to build a strong platform for communication, collaboration, transparency and insight.
Exploring the Roles
The role of the sponsor will be to develop and provide the clinical trial protocol, including primary and secondary end points, case report forms (CRF), the number of patients, the number of centers involved in the study, information about their targeted drug, certificate of analysis, storage, dosage details and information on the subject, including eligibility criteria, medical history, informed consent and adverse events information collection. At the end of each trial, site principal investigators will sign each subject’s CRF.
The CRO will be responsible for capturing the subject information at every stage of the trial. The CRO saves and loads the information into a database under the data management protocol. Finally, the CRO’s data management group will be responsible for database lock, after which the data is ready for data articulation and analysis.
How the data is managed for regulatory submission is the next priority. Companies need to analyze study data through various statistical methods to determine the impact of a product on an individual, which is what is referred to as biometrics.
Often CROs either don’t have in-house CDISC and biometrics groups or regulatory submission groups, or they may not have the resources to manage all the studies they are responsible for. The needs of the sponsor are also an issue. For example, if they have less time for data articulation and are rushing for submission, or want to have online data articulation and analysis managed simultaneously with data collection, then having that third leg in the partnership – an experienced technology partner with proven CDISC and biometrics expertise – is invaluable.
To ensure the quality of the data and analytics, it’s important that sponsors provide clear protocols for their CRFs, clinical study reports and statistical analysis plan. CROs must ensure the raw data is collected and provided to the technology partners in a clean SAS clinical standards format, and that they are ready to answer queries raised by the technology partner.
For their part, the technology partner has to provide a data conversion plan, quality control stages and publishing package plans with estimated delivery times to the CROs or sponsors. Technology providers also must be ready to update and deliver the final data quickly based on sponsors’ review and comments in order to prepare it for submission. Some technology providers will have regulatory divisions that are able to not only prepare the data but also manage eCTD submissions to various regulatory agencies globally, enabling the sponsor to leverage biometrics capabilities and submission expertise through one source.
Ultimately, the sponsor can achieve much greater clinical trial data stability and improved data analysis in a three-way partnership by leveraging the strengths, experience and reputation of each partner.
Learn more about biometrics and the steps involved to turn data into insights in our white paper, Harnessing the Power of Clinical Data.