SII BIOTECH SERVICES
SII Pharma Services Team is part of SII Life Sciences Vertical focused on serving to Pharmaceutical Companies. Pharma companies are focused on improving patient outcomes is looking for new, more effective ways to overcome obstacles. The pharmaceutical development journey comprises of Strategy, CMC, Non-Clinical, Clinical and PK
The SII team is focused on providing Clinical Services to all niche/medium and big pharmaceutical companies.
CLINICAL
Our integrated, cross-functional team approach and custom solutions move your product forward as efficiently as possible. Using proven clinical methodologies combined with our deep expertise and knowledge, we meet all applicable U.S. Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) regulatory requirements, to execute regulatory-compliant clinical trials while reducing overall study costs.
The SII team services include in the below areas but not limited to Clinical Study Design Strategy and Protocol Development
Our experts will develop a customized clinical program for your products as one size doesn’t fit all.
CLINICAL STUDY EXECUTION
-
Project management
-
clinical lab and clinical site selection, and contract negotiation
-
Clinical trials management
-
Clinical Data management
-
Biostatistics
-
Medical writing
-
Bioequivalence study design and data analysis
-
Bioequivalence risk assessment
-
Trial design evaluation, optimization and data analysis
-
Preparation and submission of the human clinical trials sections of the NDA regulatory application
SII BIOTECH SERVICES
The project manager is a critical part of a study’s success. We assign experienced project managers with proven expertise in clinical and late-stage research. The project manager is responsible for the technical and administrative aspects of the study as defined by the client.
Leadership, Communication, Results
A project manager:
-
Serves as a primary resource and point of communication for the client and project team
-
Provides leadership and direction to the project team, including specifications for time, quality and cost of deliverables
-
Utilizes SII’s global capabilities, systems and processes to assure efficiency and accuracy throughout the project
-
Creates a management framework to optimize the skills of functional leads and drives focus on the quality and efficiency of individual tasks
-
Follows the SII global risk management process, addressing potential obstacles to project delivery
-
Maintains a flexible, can-do approach to address issues innovatively and proactively
CLINICAL DATA MANAGEMENT
The integrity of clinical data is of paramount importance to a successful project. SII ensures this integrity by strict adherence to established operating and review procedures throughout every stage of a project.
SII works closely with clients to determine specific clinical technology requirements and then customizes software implementation to meet each client's unique clinical data storage and processing needs.
​
SII delivers services in several widely accepted electronic data capture (EDC) environments including Medidata Rave®, Oracle® InForm and Oracle® Clinical/Remote Data Capture. We also have standard real-time interfaces with core laboratory, imaging and other vendors, and ancillary systems to improve the speed of data acquisition and review, thereby improving data quality and minimizing timeline risks.
BIOSTATISTICS
SII’s global clinical biostatistics and programming team offers more than statistical analyses. We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance that:
-
Accelerates decision making
-
Reduces the risk of compromised timelines and errors
-
Ensures consistency and quality of global deliverables
Optimizes efficiencies with robust processes and global infrastructure
COMPREHENSIVE, TAILORED BIOSTATISTICS SERVICES
SII's extensive clinical biostatistics services are comprehensive and can be tailored to meet the needs of your project:
-
Clinical development planning, study design, analysis and endpoint strategies, as well as supporting methodologies and statistical analysis plans
-
Randomization schedule creation and integration with investigational product management, interactive voice response (IVR) and interactive Web response (IWR) systems, as well as other project planning needs
-
Scientifically sound interpretation and reporting of results with efficient, quality production of full-output deliverables
-
Real-time analysis presentations and frequent, automated and secure Web postings
-
Statistical consulting, design and operation of adaptive design studies for all phases of trials, from initial dose titration through post-approval services
COMPLETE, CONCISE BIOSTATISTICS REPORTING
Based on a well-developed plan, the statistical analysis implementation provides clients with timely, high-quality deliverables. We ensure complete, concise reporting through:
-
A centralized computing platform that unifies global biostatisticians and programmers, increasing productivity, saving time and enhancing data security
-
Analysis strategies that are International Conference on Harmonisation (ICH)-compliant
-
Production of audit-ready tables, listings and figures
-
New drug application (NDA) submission-ready data delivery in Clinical Data Interchange Standards Consortium (CDISC) format
-
Integrated submissions of statistical sections
-
Data and safety monitoring board (DSMB) output, interim analysis and investigational new drug (IND) safety updates
-
Development of comprehensive methods reports describing planned and exploratory analyses
-
Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
-
Support for manuscripts and abstracts
EXPORT STATISTICAL ANALYSIS
SII's global biostatistics team has a broad range of therapeutic experience, and our statisticians hold advanced degrees. We add value to client projects with data-driven information, analysis, interpretation and study design.