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Expert Data Services - Clinical Trial Services

Specialized Data Services for Clinical Trials
SRK’s specialized biometrics services ensure your data is handled with the highest quality and care.
Getting The Most Out of Your Data

Biostatistics

SRK provides expert biostatistics services for all phases of clinical development. Our top-tier biostatisticians are leaders in applying statistical concepts to design and execute efficient clinical trials. Supporting our clients from protocol design through regulatory submission and defense, our biostatistics team helps interpret your data so that you can make informed decisions about your clinical program.
Biostatistics Services
  • Clinical Trial Design
  • Protocol Development
  • Sample Size Calculations
  • Representation at Regulatory Agency Meetings
  • Statistical Regulatory Consulting
  • Randomization Schedule Preparation
  • Statistical Analysis Plan (SAP) Development
  • SAS Programming and Independent Validations
  • Interim Analysis Planning
  • Topline Analysis Package
  • Final Analysis Package
  • DMC Statistics Services
  • PK/PD Analysis
  • Rescue Study Services
  • CDISC Deliverables (SDTM, ADaM, Define)
  • CDISC Conversion of Legacy Data
  • Integrated Summaries of Safety and Efficacy (ISS/ISE)
  • Statistical Reports
  • Statistical Review of Clinical Study Report (CSR)
  • Manuscript Development
We advance science and health
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Client Satisfaction
Our Commitment to Quality & Information Security
SRK's fully integrated clinically focused solutions will enhance communication, streamline workflows, enable timely focused data capture, and provide optimized on-site and remote based monitoring (RBM) capabilities.
Data Management Services
  • Protocol Review
  • Optimal Technology Solution Recommendation
  • Risk-Based Monitoring Strategies
  • 24/7 EDC Helpdesk
  • EDC Access Administration
  • Data Management Trial Master File Set-Up and Maintenance
  • CRF Design and Development
  • CRF Completion Guidelines (CCG) Development
  • Subject Diary Design and Development
  • Data Management Plan Development
  • Data Validation Manual Development
  • EDC System Training for Sites and Monitors
  • Clinical Database Creation, Validation and Auditing
  • Edit Check Programming, Validation, and Testing
  • Development of Custom Status Reports
  • Adverse Event, Concomitant Medication, and Medical History Coding
  • Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
  • Continuous Data Cleaning Throughout Study
  • Query Reconciliation
  • Independent QC Review
  • SAE Reconciliation between Safety and Clinical Databases
  • Database Lock
  • Study Archival
Ad Hoc Reporting
Our ad hoc reporting suite provides study teams with the agility to transform raw trial data into actionable insights instantly. We move beyond static dashboards, offering deep-dive capabilities to address urgent safety, operational, and clinical queries as they arise.
Specialized Services and Technologies for Your Study
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Client Satisfaction
Our Commitment to Quality & Information Security
At SRK we are pleased to offer clinical operations support and full-service electronic decentralized/virtual clinical operations capabilities and state of the art, fit for use, technology solutions that allow for innovative, fully integrated, end-to-end, quality and accuracy focused value, real-time cloud-based software as a service (SaaS) solutions for conducting clinical trials.

SRK’s fully integrated clinically focused solutions will enhance communication, streamline workflows, enable timely focused data capture, and provide optimized on-site and remote based monitoring (RBM) capabilities.
Accelerated Study Start-Up and Site Activation Capabilities
  • Electronic Feasibility Surveys
  • Real-time visibility to site recruitment and performance metrics
  • Portal that provides a centralized location for accessing and sharing all study information remotely with reduced need for site visits
  • Portal that provides a centralized location for accessing and sharing all study information remotely with reduced need for site visits
Clinical Operations Services
  • Site Feasibility
  • Site Selection & Qualification
  • Site Initiation & Close Out
  • Remote Clinical Monitoring
  • Centralized Data Review
  • Risk Based Monitoring (RBM)
  • Safety & Pharmacovigilance
Fully integrated, end-to-end, quality and accuracy focused real-time cloud-based software
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Our Commitment to Quality & Information Security
SRK’s IRT randomization services can make even the most complex clinical trials run smoothly and efficiently.

Also known as IWRS (Interactive Web), IRT automates patient randomization, kit assignment, drug supply, and inventory management. Streamline your clinical trial with SRK’s comprehensive IRT solutions.
Interactive Response Technology (IRT)
  • iMedNet eClinical
  • Medidata Rave RTSM (formerly Balance)
  • Oracle ClinicalOne
  • Suvoda
For studies utilizing iMedNet eClinical, SRK internally performs all IRT development services. As experts in IRT services and solutions, SRK provides full project management/oversight from study start-up through closeout for all our IRT technology options.
IRT Features
  • Automated Randomization for Single or Multi-arm, Centralized or Multi-stratification, and Restricted & Forced Randomization
  • Inventory Management including Trigger-based Resupply, Predictive Resupply, and Drug Expiration Management
  • Seamless Integration with EDC/eClinical System
  • Comprehensive Field Level Blinding
  • Blinded and Unblinded Reporting
  • Emergency Unblinding
  • Customizable Inventory Statuses
Automating Randomization and Inventory Management
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Client Satisfaction
Our Commitment to Quality & Information Security
The Data Monitoring Committee (DMC) is an integral part of many clinical studies. SRK provides expert statisticians to analyze your data for safety review and DMC meetings.

Our team has supported DMC/DSMB meetings as subject-matter experts in a variety of therapeutic areas, including: Dermatology, Gastroenterology, Immunology, Infectious Disease, Neurology, Oncology, and Ophthalmology.
Data Monitoring Committee Services
  • Development of Stopping Rules
  • Independent Reporting Statistician
  • Voting Statistical Board Member
  • Charter Development/Authoring
  • Unblinded DMC Team Independent of Blinded Study Team
  • Table, Listing, Figure Development and Production
  • Rapid Turnaround of Ad-Hoc Requests
  • Integration of Pharmacovigilance Data
Helping You Make Informed Decisions
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Client Satisfaction
Our Commitment to Quality & Information Security
SRK is proud to be the first CRO to offer our clients a unique alternative to traditional SAE data collection and reporting.

For studies not requiring global safety reporting or surveillance, SRK offers an eSAE solution:
Safety / Pharmacovigilance (PVG)
  • allows for end-to-end safety data collection and reporting directly from our preferred EDC platforms.
  • reduces sites’ time burden while also pulling in data already entered into the AE case form.
  • integrated Serious Adverse Event, UADEs, and AESIs data collection, processing, reporting and SUSAR reporting window alerts within our validated EDC systems, iMedNet and Rave, reducing manual workload while increasing accuracy and efficiency of data entry, collection and reporting.
  • real-time notifications to specified study safety team members.
SRK recognizes the importance of robust yet flexible solutions when it comes to SAE data collection and reporting, and as such we now offer multiple integrated options to meet your safety/PVG needs.
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Our Commitment to Quality & Information Security

See How SRK Can Empower Your Clinical Decisions

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