Solvius | Clinical Research and Analytics

Indrani Kakade

COO

> 26 years of experience

Expertise: Clinical Research; Data Management, Clinical Programming and Statistics, Data Standards governance and Implementation, Safety & Risk Management along with transition and process management across broad Therapeutic Areas and Clinical Trial Phases. Strong experience in Biosimilars, Real World Studies//Data & Risk Based Monitoring.

Experience in large global projects/deployments and clinical study transitions for Clinical Trials, Data Management & Safety/Pharmacovigilance operations for major international pharmaceuticals across multiple geographies & Platforms.

Strong experience in setting up large teams ; outcome based global clinical programs, extensive knowledge of clinical research, ICG GCP, Quality Assurance, Partner /Vendor management.

Vikesh Shrivastav

Director- Biometrics

>17 years of domain experience

Expertise: Linear, non-linear statistical modelling, adaptive trial designs and Risk based monitoring

Experience in multiple BA/BE, early phase and late phase trials in therapeutic area's like Oncology, Endocrinology, respiratory, vaccines and has rich experience in IVIVC and Population Pharmacokinetic modelling.

Various publications to his credit

Maithily Sakpal

AGM Biometrics (CDM)

>18 years of experience

Experience in Clinical Research domain across Pharmaceutical, CRO and BPO industry under the areas of Clinical Data Management, Project Management and Team Management.

Strong experience in setting up an offshore Clinical Data Management unit for a Global Pharmaceutical company with end-to-end Clinical Data Management activities. Strong understanding of cross functional Clinical Data Management activities, project initiation, planning and ongoing project management skills. Strong understanding of Operations Management, project commercials, project metrics and Quality Assurance in Clinical Data Management.

Code Siva (Segment-1), a software to have centralized data for all the feasibility responses of BA/BE & Phase-1 studies inquired at Cliantha. A remarkable step towards modernization & system optimization at its best version to track the inquiries of our valuable partners. The software supports to share the feasibility responses for the study inquiries from our partners with least turnaround time. It is a connecting link between Operational teams and Frontline client responder team. On top of that, it is a reserve of our Client database in a secured manner.

Key Features :

Customized workflow
Email Notification
Track inquiry deadlines
Flexible & secure
Role based access control: for better operational efficiency, restricted access will be given each user. This will decrease risk of breaches and data leakage
Reporting and Dashboards
Quick turnaround time for responses to partners’ inquiries
Audit Trail: Comprehensive audit trial is available which follow records back to their origin. Each and every activity has been captured
Entry have been updated with time and user name along with first and last name.
Only authorized person can access the system through user ID & password. The system have been validated to operate correctly.

Indrani Kakade

COO

Vikesh Shrivastav

Director- Biometrics

Maithily Sakpal

AGM Biometrics (CDM)

Code Siva

Key Features :

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