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.

In 2014, Cliantha Research acquired Solvius LLP to widen our spectrum in realm of biometric services to deliver full-service clinical research solutions. At every step we have been exploring into new areas, evolved, pivoted, and adapted to the ever-changing landscape of healthcare clinical analytics.

This division focuses on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As experts in clinical data, Solvius provides competent outsourcing solutions for Clinical Data Management, Biostatistics, Statistical Programming.

We can offer study level support, functional service provision (FSP), strategic full data-services solutions or statistical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. By offering high quality, value-add client specific solutions to meet current and future development needs, Solvius can become your preferred partner in clinical analytics.