Our Aligned Services

Clinical Operations

• Develop Clinical Development Plan(CDP) and Protocol

• Observational and Registry studies

• Regulatory Submission

• Patient Recruitment

• Clinical Monitoring

• Imaging

  Project Management

  • Country Selection

  • Chief Investigator Selection

  • Investigators Selection

  • Contract and budget

  • Clinical Trial Management

  • Medical Monitoring

  • CTM Supply

  • Timeline

  • Patients recruitment

  • Central laboratory data management

  • Safety data management

  • Clinical Study Report (CSR)

Data Management Services

• We provides comprehensive Global Clinical Data Management services provided by knowledgeable experts with 20 years of experience equipped with state of the art technology in EDC systems & data integration.

• BPO services for pharmaceutical, Bio-metrics and medical device industry

• Statistical expertise in study design and Statistical Analysis Plan

Consulting & Strategic Leadership expertise for development of :

• Standardized clinical data management

• Standardized EDC Systems & Processes

• Standardized Clinical & Data Management reports

• Submission of Clinical Data to FDA using CDISC standards

Warehousing & Integration of Data Management Software :

• I-Review/J-Review

• DsNavigator / ARISg

• Cognos and Crystal Reports

• Clinical Trial Management Systems (CTMS)

Operational Data Management Services :

• e-CRF and Paper CRF Design and Production

• Database Design

• Double Data Entry and Verification

• Remote Data Capture

• Patients Screening Log

• CRF Review

• Query Management

• Medical Coding

• Laboratory Data Administration and Radiology Images

• Edit Checks and Data Validation QA audits

• CRF/Edit Check Log and Tracking

• AEs/SAEs Reporting, Submissions and tracking

• External Data Loading & Reconciliation(Lab,ECG, PK)

• SDTM data submission/transfer to FDA

Bio-Statistical Services

• Clinical Trial Design

• FDA meetings/materials, executive summaries, ISS & ISE

• Sample Size Calculations

• Statistical Input to Protocols

• Generation of Randomization Code

• Statistical Analysis Planning and Interpretation

• Interim Analysis

• Generate Top Line results

• Statistical Reports

SAS - Programming Services

• SAS Datasets Creation

• SAP Programming

• Program Documentation

• Program Validation

• Data Listings, Tables, and Graphs

• Integrated Summaries of Safety and Efficacy Programming

• Electronic (e-NDA) Submissions

• Version Control and Archiving

Regulatory Affairs Capability

• Regulatory

  • Pre-IND meetings, IND preparation

  • End of phase 2 FDA meetings

  • On going protocol related questions and answers

  • Investigator Drug Brochures

• Regulatory Submissions

  • FDA

  • EU Commission, European countries

  • MHLW, Japan

  • DCGI, India

  • Support IND & NDA submission

Medical Writing

• Generate Clinical Study Reports and Documentation

• Protocol writing

• Interim and Final clinical study reports

• Investigator’s brochures

• Integrated summaries of efficacy and safety

• Manuscripts for publication

• Abstracts for National and International meetings

• eCTD preparation and assembly

• FDA briefing materials

Pharmacovigilance & Drug Safety Services

Our Pharmacovigilance domain provides management for pre-authorization and post-marketing product safety programs by facilitating rational assessment of product benefits and risks, protection of research subjects and patients, rational and appropriate clinical research program evolution, registration and labeling composition and decisions to support continued product commercialization at market place.

Our Advantage:

SAE/AE Initial Intake and Handling including Call center support, Adverse event (AE) and serious adverse event (SAE) intake, documentation (“log in”) and data entry Case Report Characterization Facility, pose additional questions based on nature of report, consideration of clinical features of disease under study and co-morbidities, and consideration of effects of concomitant medications, drug-drug interactions

Epidemiologic Perspective for Marketed Product Reports with Disease burden and prevalence and consideration of utilization patterns of alternative therapies.

Internal Processing – Data Management with AE and SAE log-in, tracking, coding and SAE case processing, MedDRA and WHO-DD coding, medical quality review, AE and SAE evaluations, SAE narrative composition, physician medical review and signal detection, Pertinent literature reviews and summaries, adverse event reporting, electronic submissions to European authorities of individual case safety reports (ICSRs); and to US FDA and Canadian TPP (via an ESTRI gateway), electronic SAE/AEs reporting to FDA , generating safety database to document and report SAE/AE, fully validated 21 CRF Part 11 compliant database that supports multiple products and studies, and routine back-up and disaster recovery systems and procedures are in place which are essential for safeguarding the data.

Regulatory focus with FDA's Good Pharmacovigilance Practices i.e 21 CFR 312.32, 310.305, 314.80, 314.98, 600.80, guidance on Premarketing Risk Assessment (Mar 2005), guidance on Risk MAPs (Mar 2005), guidance on GPPs and PE Assessment (Mar 2005), EMEA’s European Clinical Trial Directive (2001/20/EC) guidelines and focus on End-User perspective, so physician/investigator and patients/subjects can understand the risks and benefits associated with use of a particular medicine and SAE reconciliation between clinical study database and drug safety database (for clinical trial reports)

Expertise in post-marketing signaling, pharmacoepidemiologic techniques (e.g., population at risk background incidence/prevalence statistics) and directed literature reviews to place an internally-generated signal into clinical perspective, expertise in pre-registration signaling, and strength of post-marketing signal assessments and their implications for recommended courses of action (e.g., label revision, Risk MAPs, post-marketing safety studies [PASS] up to and including design and conduct of registries.

Pharmacovigilance and risk management consulting with assembly of post-Phase IIa pre-registration RMP, assembly of a pre-registration RMP, assembly of an RMP for a marketed product, safety signaling programs (Phase I), frequent investigator conferences to discuss clinical & lab safety data findings, Implement additional case characterization queries for SAEs, success to specialized Phase I study services (e.g., ICH E14 ‘thorough QT studies), safety signaling programs (Phase IIa – IV), conferences to discuss positive safety data findings including representation at FDA/EMEA conferences, access to FDA AERS and WHO databases, and literature-based drug class perspective evaluations.

Phase IIa through Registration Risk Management Data Services and Report Composition with DSMB establishment and management, adjudication committees for critical clinical trial safety endpoint, data and dictionary management, development of grouped definitions, reference files for signaling data and pre-registration RMP development.

Post-Marketing Risk Management Data Services and Report Composition with assembly of External Expert Advisors and Advisory Committee, coordination of the Sponsor’s Data Assembly for an RMP, RMP updates, pharmacoepidemiologic and Post-Marketing Surveillance data coordination and report writing, reference files for signaling data, coordination of PSUR and RMP Data Content and Submission Timetables.