Samad Infotek’s mission is to provide its customers with exemplary customer-focused service that provides a unique blend of cost-effective and creatively *enriching pharmaceutical, Biotech, CRO, IT staffing, clinical studies, Project Management, Software Solution and clinical Trial services.
SII BIOTECH SERVICES
SII Biotech Services Team is part of SII Life Sciences Vertical focused on serving to Biotech Companies. SII Biotech is committed to providing comprehensive services, integrated clinical and commercial solutions designed to help biotech companies move forward in their effort to get treatments to your treatments to the patient for first in human through Phase IV and post-marketing follow-through, launch and commercialization. We combine the global power and capabilities of SII with the hands-on approach, dedication and innovative mindset that drive the success of biotech companies such as yours.
LAUNCH STRATEGY &
Comprehensive product development services to address multiple drug development challenges and the growing complexities of conducting multinational clinical programs.
Our experience, support systems and infrastructure enable us to provide the highest level of program management and clinical development services for Phase II-IIIb clinical trials.
Our Services include:
Global infrastructure and support
Quality processes and accurate reporting
We advance a product through development and approval on time and within a client's budget. Our experienced teams deliver quality results for our clients' drug research and development needs.
GLOBAL PROJECT MANAGEMENT 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.
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 EXPERIENCE, TAILORED BIOSTATICS 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 EXPERIENCE, TAILORED BIOSTATISTICS SERVICES
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 Harmonization (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
EXPERT 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.
ANALYTICS & PATIENT STRATEGY
We develop a long-term strategy to help avoid costly amendments down the road once the product landscape and market has been identified. Incorporating real-world data in the clinical development plan supports decision-making throughout the drug development process, boosting confidence in the selected path forward. This comprehensive plan will provide a roadmap for key activities – including cost and timeline factors – for key stakeholders. The strategies followed by our team TA Strategy, Regulatory Strategy and Plan, Clinical development strategy
LAUNCH STRATEGY & PLANNING
We develop a comprehensive plan with a well-defined brand, value, and channel strategy, you can secure market access and establish a path to optimal product launch. SII Biotech’s proven launch strategies and connected insights, refined from the previous launches, can provide you with the insights and resources to help you develop a market-backed, evidence-driven commercial plan
Accelerate the time to implementation, launch and maintain your business, and adjust rapidly post-launch. We can help you streamline your operations and gain valuable visibility into market forces. Let our global and local healthcare and functional experts provide you with the actionable insights and resources to help you accelerate your commercial success and get your product into the hands of the patients who need it. We help in multiple ways but not limited to Multi-Channel marketing implementation and tracking, pricing and market access strategy and implementation, Trade, compliance and transparency.