The journey of the drug development process spans to more than a decade with multiple challenges from early to the late Phase. Our Early Phase Clinical Development programme facilitates concept development, protocol development, scientific advice and consultation, Statistical design, data management and clinical monitoring to execute your PK/PD studies.
Our Global alliance partners augment our Early Phase Capabilities with appropriate infrastructure and capabilities and help you take your clinical trial development programme to the next phase.
With our team’s integrated and comprehensive clinical operations approach, we offer accelerated timelines and reduced expenses for your phase I Clinical Trials. Additionally, our global SOPs are well established, so we’re ready to commitment for execution of your Phase I clinical trials when you are.
Proof of Concept and dose ranging studies form a part of our expertise & offerings where we use an integrated and adaptive approach that supports your Phase IIa outcomes.
Our Phase III Clinical Development capabilities are focused towards enhanced scrutiny of your fledgling product. In this phase we have intrinsic capabilities to execute studies related to safety, efficacy, placebo control, active comparison, Bioequivalence studies with clinical endpoints & quality of life studies.
In our Phase IV clinical development programme, we mainly focused to offering integrated post approval regulatory commitments & support for the primary indication. PMS, new indication studies and labeling studies.
Stakeholders of the Phase IV clinical development programme include regulators, payers, physicians, and patients all need to be satisfied that your drug or device is safe, effective, and offers greater value or benefit than current standard of care.
When marketing authorization is in progress, we’re ready to help you connect the dots and sustain the clinical development programme cycle.