Doctor typing on computer

Clinical research - an industry in change

Accelerating clinical trials

The rapidly changing clinical environment is motivating clinical leaders to assess their current systems and processes to determine how well they are positioned for future requirements. They face persistent pressure to streamline activities with the goal of accelerating clinical trials.

Simultaneously, the increasing popularity of decentralized trials (DCTs) is creating new challenges for clinical stakeholders. New patient-centered technologies are being implemented resulting in larger volumes of data, in a variety of formats, collected from multiple sources. Innovative trial designs are adding complexity while the constant demand for compliance remains a priority. The multitude of industry drivers makes it difficult to achieve operational excellence in such a variable environment.

Assessing new operational requirements

As global Clinical teams conduct operational evaluations and determine their path toward future capabilities, they often need external assistance. A holistic evaluation of emerging technologies, evolving regulations, current practices, and future capabilities typically requires a broad understanding of the clinical business.

Organizations of all sizes choose NNIT as the trusted partner to lead clinical optimization projects. Our foundational services provide the building blocks for teams to create meaningful (data-driven) change across Clinical Operations and Clinical Data Management.   

The Technology Enabled Clinical Trial

Clinical Trials today, requires a multitude of systems supporting the clinical trial conduct - some manual and some electronic, with data and content in many instances managed in separate, fragmented and non-integrated IT applications, such as Electronic Document Management System (EDMS), Electronic TMF (eTMF), Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Statistical Computer Environment (SCE) etc.

While these IT solutions supports our individual clinical trial activities, the data and content generated and managed in these are typically siloed, hindering end-to-end process optimization, efficient collaboration and oversight while requiring significant workarounds and at times resource heavy manual data entry and duplication between systems.

The Clinical Transformation starts with a unified platform, enabling seamless data and content management, standardize data models and use cases, improving both compliance and operational efficiency.

Compliant and Secure

Data security, patient privacy and compliance are essential components of a successful Clinical transformation journey. With the life science industry increasing patient engagement and extensive use of personalized data, global regulatory entities are equally looking towards new regulatory measures to ensure the integrity, privacy and security of data and data use. Compliance is a license to operate within Life Science and must be considered every step of the transformational journey.

Bridging the Gap Between Business and Technology

NNIT understands the clinical space; its stakeholders, processes and technology. With more than 20 years of experience working within clinical operations and data management, NNIT has supported customers on their transformational journey across all NNIT service offerings from advisory and implementation, validation, migration to application services etc.

We recognize the importance of experience and combine Clinical subject matter expertise with industry best practices to provide customer a pragmatic and efficient approach to transform their Clinical Operations.