Services
We provide a wide range of Services
Clinical operations, Data management, Site management services, Regulatory Affairs, Biostatistics, and Ethics committee submissions and approval.
CLINCIAL OPERATIONS
- Our large integrated clinical site network, database and existing site relationships will ensure rapid identification of the right investigator and patient populations providing access to precise patient cohorts not only accelerating site startup but also enabling predictive and prognostic biomarker-based patient stratification. By leveraging the most appropriate communication channels we attract and retain a diverse and broad prescreened patient pool.
Custom study-specific patient education material will be used to ensure maximal patient recruitment and retention. While we provide flexibility with access to decentralized and hybrid trial options, we pride ourselves in developing a wide number of clinical sites to support and enhance recruitment at the site level. Our site facing staff and local patient recruitment resources provide a unique opportunity not just to find the right site but also to maximize the site’s recruitment potential with innovative and site-specific solutions. Our site liaisons will also work closely with site staff to coordinate recruitment, patient screening, and data reporting.
- Our Patient and Site facing solutions that include targeted and customized site support incorporate early, clear, and transparent engagement making it easier to enroll and retain patients and sites in clinical trials to ensure unparalleled predictability and consistency in trial recruitment outcomes. Another key aspect is our investment in patient focus groups and surveys that support research which provides key patient insights to optimize our study feasibility, patient recruitment, and retention projections. These efforts also enable customized study protocol specific recruitment strategies and solutions that leverage the patient perspective to align with the studys’ target patient population.
StratifyBioZ services include but not limited to
01.
- Feasibility assessments
- Clinical site evaluation and selection
- End to end project management support
- Vendor evaluation and management
02.
- Clinical trial master agreements
- Regulatory compliance consultation
- Health authority submissions and approval
- Ethics committee submissions and approval
03.
- Site Initiation and Monitoring
- Data management
- Site close out
- Sample and data archival
- Support CSR and study close out activities
SITE MANAGEMENT SERVICES
Optimal site management is a key tenet of clinical trial operations to ensure success in the clinic. Our highly skilled site monitors are well positioned to train investigators and site staff on protocol requirements, inclusion/ exclusion criterion, best practices, data capture as well as mandatory and optional study procedures.
Each of our studies have a dedicated Study Start-Up (SSU) team with an experienced study manager to coordinate all aspects of site selection and activation, contracting, budgeting, vendor integrations, ICF compliance, IRB/ EC submission as well as Indian health authority interactions and regulatory filings.
SSUs review study protocols with sponsors to identify elements directly impacting recruitment. SSUs use advanced analytical tools to define study specific benchmark metrics, monitor progress, and record critical milestones to ensure detailed and transparent trail status reporting.
The SSU team also enforces centralized and study-specific training materials and SOPs to ensure inspection-ready compliance at all times. SSUs strive for early engagement, strategic planning, and clear communication to develop an integrated site startup and maintenance plan for the study. This dedicated study-specific SSU model ensures maximal enrollment, optimizes site selection for the trail design as well as fast and efficient data sharing to enable informed decision-making for the study sponsor. We offer services to empower sites to maintain regulatory compliance and protocol adherence.
StratifyBioZ services include but not limited to
01.
- Site education to ensure protocol compliance
- Site education on clinical trial and drug supply management softwares
02.
- Ethics committee submissions
- Assignment of study specific research coordinators to track enrollment, adverse event reporting, on-site monitoring and data collection to ensure oversight for
protocol/ regulatory compliance
DATA MANAGEMENT
Our integrated data management platform provides an opportunity to streamline, and manage clinical datasets that seamlessly integrate clinical sites with clinical, bioanalytical and biomarker laboratories to enable healthcare compliance grade data management and analytics.
This enables faster access to high quality and meaningful data for accelerated decision making and risk assessment earlier in the trial. Our central clinical trial monitors help integrate risk-based and centralized surveillance to continually review and analyze subject-level safety data to provide key insights to the clinical site directly impacting patient safety, study conduct and introducing operational and clinical monitoring efficiencies.
- We leverage our machine learning, artificial intelligence and predictive analytics tools for more precise decision-making, mitigate risk, and improve study quality while making centralized risk-based monitoring a reality
Our data management team and processes are 21 CFR Part 11 compliant and can deliver high-quality clinical data in a timely manner. Where possible our workflow has been automated to ensure strict adherence to compliance and enhanced data flow for a more efficient way to manage risk and enable data-driven decision making.
StratifyBioZ services include but not limited to
01.
- CRP/ eCRP guidelines development and database design
- Support development and execution of data management plan
02.
- Data entry, verification and validation
- Data query resolution
03.
- Database Lock
- Safety database design and implementation
04.
- SAE data reconciliation
- Data integration
QUALIETY ASSURANCE
Our dedicated and independent quality assurance department provides oversight over all clinical trial activities to ensure GCP, ICH, protocol and local HA regulatory compliance.
In addition to ensuring that the appropriate quality systems are in place, the QA team performs periodic internal audits including study design, clinical site activities, data generation, drug supply, external laboratories and final CSR for utmost data integrity and quality.
StratifyBioZ services include but not limited to
01.
- Design and implementation of quality processes and systems
- Conduct and reporting of internal process and site audits
02.
- Vendor qualifications
- Investigator trainings
03.
- CAPA implementation and compliance
- Design and implementation of SOPs
REGULATORY AFFAIRS
Through our regulatory affairs department we offer a full range of regulatory services to ensure regulatory compliance in clinical trials
With deep expertise in Indian regulations, we serve as the single point of contact connecting Indian health authority, IRB/ EC, clinical site and the sponsor for seamless and transparent trial conduct. Our team’s expertise in regulatory consulting would support both sponsors and investigators to stay compliant while accelerating regulatory submissions and approvals.
StratifyBioZ services include but not limited to
01.
- Preparation and submission of regulatory documents for Clinical Trial Approvals
- Import licenses for investigational drug
02.
- Export licenses for biospecimens
- Presentation of protocol to regulatory authorities
03.
- Registration of clinical trials in national registries
- Safety reporting
BIOSTATISTICS
Our statistics and programming team delivers biostatistics and data analysis services to support everything from protocol design to delivery of CSR.
StratifyBioZ services include but not limited to
01.
- SAS programming
- Sample size calculation
02.
- Choice of primary and secondary endpoints in the protocol
- Design and execution of randomization plan
03.
- Design and execution of statistical analysis plan
- Statistical input on CRF and eCRF design
04.
- Delivery of tables, figures and listings for safety and PK/ PD data
- Interim analysis and end of study analysis
REAL WORLD EVIDENCE STUDIES
Real world data and real world evidence studies are playing an increasingly important role driving key decisions in the clinic.
StratifyBioZ services include but not limited to
01.
- Execute real world evidence studies across therapeutic areas
- Leverage decentralized and hybrid trial options
02.
- Execute on innovative trial options to deliver customized real world datasets to fit sponsors real world evidence strategy
- Deliver real world data to support commercialization of investigational drugs and medical devices