Industry Standards

This educational section will provide curated educational resources, as it relates to standards within the
industry regarding the data we capture, clean and analyse in the biopharma industry.

Originally driven by the needs of regulators and drug development companies to ensure
consistent requirements in assessing safety and efficacy of new medicinal products, the advent and
evolution of biopharma industry standards have enabled increasing quality and efficiency in drug
development, safety monitoring and health authority review of product marketing applications.

Dating back to the late 1980s and early 1990s, the use of computers by health authorities, particularly
the US Food and Drug Administration (FDA), to improve efficiency in their review of new
drug applications drove the transformation from the paper-based health authority submissions of the
past to the electronic (digital) submissions of today.

The increased use of computerised systems, along with the formation of the International Council
for Harmonisation (ICH), the standardisation of documents and data became essential to enable quality
and efficiency in drug safety monitoring and product application reviews by health authorities. As a
result, the Clinical Data Interchange Standards Consortium (CDISC) was formed in 1997, a
joint initiative of industry experts and the FDA to develop data standards suitable for use across the
industry. Over time this has facilitated data harmonisation for submission, globally, to health authorities
while also enabling organisations to build automation into their data flows and reporting tools.

Of note, the collaborative efforts of three key industry organisations have played
an integral role in influencing and driving the development of industry standards pertaining to data
capture, cleaning, analysis and reporting. These organisations are the International Council
for Harmonisation (ICH), the Clinical Data Interchange Standards Consortium (CDISC)
and TransCelerate BioPharma.

The ICH (International Council for Harmonisation)

The ICH is a non-profit organisation formed in 1990 based on the need to harmonise the requirements
of health authority regulators across Europe, Japan and the US for approving and authorising new
medicinal products. The ICH has since expanded to include health authority regulators globally.

Guidelines published by the ICH span a variety of topics that include processes, documents and specific
data and analysis requirements. ICH Efficacy (E) Guidelines and the Medical Dictionary for Regulatory
Activities (MedDRA) are examples of guidelines and standards that impact data and analysis standards in
the biopharma industry.

More information can be found on their website (ich.org).

CDISC (Clinical Data Interchange Standards Consortium)

CDISC is a non-profit organisation with a focus on the development of data standards supporting
the clinical research process. Originally formed in 1997 as a volunteer organisation, CDISC has brought
together experts in the industry to align on common data structures and data content spanning both
nonclinical (animal) and clinical (human) studies.  

Originally focusing on common data domains in clinical trials, e.g. de mographic information, adverse
events, routine lab results and subject status, CDISC has expanded to other domains, such as therapeutic
area disease-specific standards, specialty lab results and nonclinical studies.

Today, CDISC continues to evolve in evaluating a new source of data, referred to as “Real World Data”,
which includes data such as electronic medical records, insurance claims data and wearable devices.

As a result, CDISC standards are now widely used across the biopharma industry and have become a
requirement for data submissions to some health authorities (e.g. the FDA, PMDA, NMPA).

For detailed information about the CDISC industry standards, visit the CDISC website (cdisc.org). This
website provides information for a variety of
users, including academia, pharmaceuticals, software developers and regulators. Details of CDISC
standards are provided, as well as available education and training programmes regarding CDISC
standards interpretation and use.
 1 - CDISC Primer - Introduction into CDISC Standards

TransCelerate BioPharma
TransCelerate BioPharma is a non-profit organisation driving collaborations across the industry to
enable faster and more efficient global biopharmaceutical research and development.

Since forming in 2012, TransCelerate has brought together experts from health authorities, academia,
industry groups and research organisations, employing the core principles of sharing information,
streamlining processes and leveraging tools and technologies to create efficiencies across the
industry, ultimately improving the patient and site experience and advancing innovation in clinical
research.

TransCelerate has a variety of industry initiatives ranging from Interpretation of Guidances and
Regulations, Investigator Registry, Clinical Data Transparency and Advanced Safety Analytics, to name a
few.

More information about TransCelerate, their strategic priorities and related initiatives is available on
their website (transceleratebiopharmainc.com).

Health Level 7 (HL7)

While CDISC is primarily focused on the definition of standards used in clinical trials and submission
standards, HL7 has as its mission the goal of providing reliable standards for the exchange, management
and integration of data that support clinical patient care and the management, delivery and evaluation
of healthcare services. HL7 encourages the creation of flexible, cost-effective approaches, standards,
guidelines, methodologies, and related services for the interoperability of healthcare information
systems. HL7 provides a forum for the effective and efficient communication between the constituents
of the healthcare community, as represented by its membership: an international community of
healthcare organisations, vendors and developers of healthcare information systems, consultants and
systems integrators, and related public and private healthcare service agencies.

While CDISC is primarily focused on the definition of standards used in clinical trials and submissions to
regulatory agencies, HL7 is focused on the definition of standards utilised in real-life healthcare services.
With the advent of real-world evidence or the inclusion of electronic health records in clinical trials,
these two worlds however merge together.
With the publication of the Fast Healthcare Interoperability Resources (FHIR) draft standard, a paradigm
change was introduced. The alignment between terminologies is a known problem and groups such as
the CDISC EHR to CDASH (E2C) are looking to come up with a shared semantic layer between the data
standards (as well as work previously done with the CDISC BRIDG model).

New Horizons
With recent advancements in technology and expanded data accessibility, e.g. cloud-based systems,
machine learning and the internet of things, the data landscape in clinical trials is evolving. Historically,
data was curated through a data capture system and stored in a structured, relational database format.
However, as new sources of data become accessible, such as electronic health records, claims
data, wearable devices (e.g. Apple watches) and digitally generated imaging files, data formats have
become disparate, some structured and some unstructured. Therefore, data engineering/data science
methodologies and technologies will play a critical role in shaping the continued evolution of standards
in the biopharma industry.

Reference Materials
Recommended PHUSE Materials

Recommended Readings

Recommended Videos

Recommended Websites

• ICH (International Council for Harmonisation), https://ich.org

• CDISC (Clinical Data Interchange Standards Consortium), https://cdisc.org

• TransCelerate BioPharma, https://transceleratebiopharmainc.com/

• HL7 (Health Level Seven), https://hl7.org