Services

Innovatis offers end-to-end support across Phase IIB to IV and PK/Clinical endpoint trials. Our expertise spans from regulatory writing to the delivery of final clinical study data and reports, all in strict adherence to regulatory standards. Additionally, we provide comprehensive safety reporting throughout the clinical trial process.

Clinical Trial Management

offers end-to-end support across Phase IIB to IV and PK/PD Clinical endpoint trials. Our expertise spans from regulatory writing to the delivery of final clinical study data and reports, all in strict adherence to regulatory standards. Additionally, we provide comprehensive safety reporting throughout the clinical trial process.

BA/BE Study Management

Pharmacokinetic Study Oversight

Our Expertise

Innovatis is equipped with the resources and expertise to manage trials for Pharmaceuticals, Biopharmaceuticals, Nutraceuticals, Medical Devices, and Cosmetics.

01. Clinical Trial Management

- Phase I-IV study execution
- Site feasibility and selection
- Investigator and site staff training (ICH-GCP, protocol, EDC, IWRS)
- Logistic & administrative support
  - PK Kits handling
  - IP management
  - Biological sample shipment
  - Central lab management
- Clinical Monitoring
  - Overall QC and QA services
  - Oversee data collection
  - Ensure regulatory compliance
  - Resolve data queries
  - Review source documentation and case report forms
  - CRAs are typically dedicated to one protocol at a time to maintain quality
  Medical Writing
  Clinical Trial protocols
  Case Report Forms (CRF/eCRF)
  Informed Consent Documents (ICD)
  Investigator Brochure (IB)
  Patient Information Sheets (PIS)
  Patient Diaries (PD)
  Clinical & Non-Clinical overview reports
  Clinical Study reports
  Safety Aggregate reports
  Clinical Project Management
  Clinical Study Contracts & Budgets, management of SOW and Project Timelines
  Coordinate with sites and competent authorities on behalf of Sponsor
  Trial, Site, Patient Management, and CTMS
  In-house and On-site Monitoring Management
  Inspection & Audit Readiness, CAPA, Risk Assessment and Mitigation Plans
  RTSM
  Statistical Analysis Services
  Statistical consulting on study design
  Statistical analysis and reporting
  Development of the statistical analysis plan
  Sample size and power calculations
  Study randomization schedule
  Writing statistical sections of the protocol & reports
  Tables, listings, figures and annexures
  Development of CDISC, SDTM, and ADaM datasets with documentation and validation as per the applicable regulatory requirements
  Clinical Data Management
  Electronic case report form (eCRF) design
  Database design and study setup
  Medical coding to industry standards
  Data validation and query resolution
  Management and reconciliation of third-party data
  CDISC study data tabulation model mapping and consolidation
  Bioanalytical Services
  Extensive experience with both small & large molecules
  Excels at creating custom solutions for clients’ most challenging problems/methods
  Pharmacokinetic sample analysis
  Large molecule services
  PK/PD/lmmunogenicity assay for Biosimilars or large molecules
  Development and Validation of robust custom assays
  Extensive LC-MS/MS experience
  Clinical Vigilance Services
  Signal Detection & Management
  AE & SAE Case processing
  DSUR /PSUR reports
  MICC

02. Our Clinical sites network

We have an extensive clinical site network across India in the following therapeutic segments

Autoimmune
Dermatology
Endocrinology
Genitourinary
Antipsychotic
Oncology
Ophthalmology

03. BA/BE Study Management

At Innovatis, Our early-phase portfolio includes BA/BE studies, Phase I studies (conducted in healthy participants and special populations) and PK/PD & patient studies (conducted in special populations). Our BA/BE study services are fully compliant with global regulatory requirements.

Extensive Cardiac Monitoring Studies
Bioanalysis of first in human studies
PK/PD & Clinical end poin studies on healthy participants & patients
Palatability evaluation studies
Pharmacokinetic & Biopharmaceutics
Studies on special populations – healthy female, PMW & elder participants
Medical writing services: Protocol development, ICD, ICF and Clinical study repots
Statistical analysis and Population BA/BE analysis
Proof-of-concept studies (PK Studies)
Bioanalytical services: For small & large molecule analysis and elemental analysis
Data Management & CDISC services
Glucose Clamping studies
Pre-clinical PK sample analysis

04. Drug Safety & Pharmacovigilance

Our pharmacovigilance team support post-marketing safety surveillance and clinical trial and across the globe. As patient safety as the critical component, our quality focus aligns us to collaborate with Pharma and Biotech companies to provide both standalone and integrated services throughout the lifecycle of a product.