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 CRM is a web-based client feedback management system that is used to gather feedback on our services providing to the clients and to identify areas for improvement through the statistical and data analysis.

Important Features/Functionalities

Secure access through user ID, password and integrated with active directory domain, single sign on (SSO) process
User management, role management, master management (Like Client master, business verticals and services master, etc..) configuration
Dashboard functionality to view client(s) details, map view for Cliantha’ s client(s) across the world, recently received client feedback and view feedback status.
Functionality to design Client feedback form with dynamic controls.
Functionality to configure e-mail settings, reminder, and client feedback form setting
Functionality to map user wise client POC/representatives
Services wise (e.g., Early Phase, Late Phase) and client POC/representatives wise feedback link generation facility
Functionality to view feedback status report with data output facility (Excel output)
Functionality to analyse feedback data through different methods {Chart’s view, excel data Output, statistical chart output, etc..}.

Indrani Kakade

COO

Vikesh Shrivastav

Director- Biometrics

Maithily Sakpal

AGM Biometrics (CDM)

Code CRM

Important Features/Functionalities

Let’s Talk

Phone

Address

Email