Jubilants
therapeutically aligned clinical development capabilities provide
collaborators a seamless transition from preclinical through
translational and early stage development. This is further augmented
by Jubilants ability to provide global access to late stage
development (Phase II-IV) across Europe, USA and India.
Clinsys Research, the clinical research groups within DDDS,
provides pharmaceutical, biotechnology and medical device companies
with a broad range of clinical research services in support of Phase
I-IV drug and device development, including project management,
clinical monitoring, scientific and medical support, investigator
and patient recruitment, site management, biostatistics, data
management, EDC, drug safety, quality assurance, regulatory affairs,
strategic sourcing and medical writing.
Highly efficient globally leveraged project management teams are
supported by therapeutic experts in areas of dermatology, central
nervous system, oncology, respiratory and cardiovascular providing
collaborators with strategic and operational support from study
design through regulatory approvals.
The Clinical Research group seamlessly integrates with customers or
Jubilants discovery and pre-clinical infrastructure to provide
high quality and highly efficient translational and clinical
development solutions to include:
- Scientific foundation
- Therapeutic Program Strategists (Clinsys TPSTM)
- Phase I unit (BA/BE, PK, generics and pre-formulation
- Trial design
- Scientific advisory board per each therapeutic area
- Sites/ Patients access
- Global investigator network
- Global feasibility
- Expedited patient enrollment
- Site training and validation
- Technology
- Clinsys Trialstat CA, the first software as a service
(SaaS)- based electronic data capture (EDC) system in the
industry.
- Strategic alliances with vendors across multiple
platforms and systems.
- Precision, execution and accountability
- Clinsys Global Project Solution (Clinsys GPS) Executive
steering committee assigned to each project.
- Shared metrics/ transparent processes