The life sciences industry is a rapidly evolving, innovative space with both small and large players contending to bring novel, life-enhancing products to the marketplace. While the emergence of new drugs and devices have been advantageous to such companies, they struggle to thrive in the market due to tightening regulatory guidelines, data integrity, differential drug pricing and so on. To make things worse, medical device and pharmaceutical supply chain is becoming highly complex, tiered and globalized. Within this new environment, the pharmaceutical industry is finding it hard to cope with the pace of innovation patients aspire and investors expect.
How we help?
We along with leading research institue work closely with pharmaceutical, biomedical and biotech companies to achieve disruptive growth and productivity in their business through automation. We help companies to collect mission-critical data, enhance transparency across supply chain and improve collaboration between suppliers, partners and customers. Our solutions bolster operations with:
1. Productive R&D activities
2. Reinvented value proposition
The advancement in technology has equipped us with powers like Electronic Data Capture (EDC) systems, integration capability, IxRS, wearable devices, APIs and many more. However, there is a need to leverage it's maximum usage potential to develop better management of patients, trial, cost and RoI.
Our expertise in implementing CDMS systems has helped organization overcome challenges faced in using EDC/ CDMS systems. We deal with varying needs of organizations that include
• Offline data capture
• Digital tablet supported
• BYOD supported
• Secured dedicated cloud server
• Live dashboard view of trial status
• Speech recognition
• Finger print ready
• Gamification ready
• Community engagement
Our Services (Implementation/Support)
Clinical Service Landscape
Clinical Operations Service Offering
Clinical Data Management Service Offerings
Biostatistics Service Offering
Clinical Systems Implementation Service Offering
Clinical Systems Integration Service Offering
Our integrated Drug Discovery Services are designed to reduce your costs and timelines, helping you meet your drug discovery milestones. Our research team has many years of discovery experience to fully assist drug discovery, SciInformatics provides unique drug discovery services that span the entire drug discovery life cycle and support both target-based and phenotypic discovery.
With well enabled capabilities in Oncology, Metabolic Disorders, Pain, Inflammation, Toxicity and Fibrosis, SciInformatics has rapidly emerged as a leading collaborator for biotechnology and pharmaceutical companies.
We offer drug discovery services including docking molecular, drug target identification, drug discovery screening – small molecule screening, library screening, ion channel screening – fragment based drug design, ligand based drug design, ligand protein binding, protein ligand docking calculation and prediction, drug profiling, lead identification, lead compound identification and lead optimization.
The process from initial target identification and validation, high throughput screening, hit identification and lead optimization to preclinical candidate selection cannot be considered a routine activity. Significant intellectual and innovative input is required from experienced scientists across a variety of disciplines and backgrounds to discover a quality drug candidate. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles and move us forward together on the journey of getting new drugs to market.
With numerous technologies for hit identification, coupled with our knowledge-based approach to advance compounds from hit-to-lead into lead optimization, our integrated research teams consistently convert leads into successful preclinical development candidates.
Speciality Research Service Offering
Some key challenges faced by CRO organizations are
How can I effectively use externalization without losing oversight and control of my studies?
How can my team people deal with multiple complex user interfaces?
How do I manage my IT costs, especially if I have to integrate all these different systems for each study?
How can I report on data distributed across all these different clinical systems?
How do I implement an IT infrastructure that provides the adaptability to meet my unique and evolving business needs?
SciInformatics has some key business propositions in managing and reporting of clinical and safety data. Our approach is to provide guidance alongside our deliverables. We are involved from the design of a study through to final submission.
key value proposition
Process Efficiencies: Human-to-Human or Human-to-System or System-to-System
Business Activity Monitoring: Workflow enabled events drive process automation & efficiency
Advanced Process Control; Real-time dashboard reporting, robust audit trails, and ad-hoc report wizard
Enhanced Integration Capabilities: Leverage existing enterprise application capabilities and/or integrate directly via adapters.
IT Efficiencies: Reduce development timelines via configurations & rule engines, Enforcing reusability of components, real-time reporting & analytics
Our key service propositions are:
• Cost effective solutions (EDC, CTMS, Safety, Portals) on SAAS or utility model
• Recruitment forecasting using their current landscape
• Web-based study start-up solutions
• Clinical supplies tracking & forecasting
• Standards implementation and management with the required customization
• Data integration services
• Biostatistics and statistical programming services
• Ad hoc reporting services
• Pharmacovigilance (Drug Safety) services
• Signal detection & risk management (REMS, EU-RMP) services
• Call / Contact (Product Support) Centers
• Interactive data analytics & real time reporting services
• Enterprise application integration & web services
• Legacy data to standards conversion
• Portals & KM
• IAAS & SAAS
• Data mining & Data warehousing
• Stakeholder surveys
Integrated Data Hub
While there is always a change in global Compliance rules, most of the regulated Life sciences companies are struggling to cope up with these frequent changes. Moreover, every day regulatory agencies are tightening the rules. This again is creating extra trouble to these organizations. Hence Life sciences companies need to build a strong compliance foundation.
SciInformatics has a strong track record in helping companies manage compliance issues. Knowing that success requires a holistic approach, our operating model helps you comply with industry standards. Our best practices focus on information security management, FDA guidelines on system validation and electronic records and signatures.
Matured Center of Excellence for Regulatory Compliance
Industry experts with hands on experience in ensuring process and IT compliance in alignment with Regulatory requirements.
Regulatory consultants working across the globe.
Industry leaders at the micro vertical level with hands on experience across the pharmaceutical product life cycle.
Excellent understanding of the processes involved in the functional areas where the scientific supporting documents are prepared for the regulatory submission.
Enhanced by Life Sciences Quality Management Hub
Life Sciences Quality Management System
Software Quality Assurance & Enterprise Quality Management
Expertise in the New approaches to Quality
Excellent knowledge on the recent developments such as QbD, QRM and PAT
Our Approach for Product Validation
What we offer?
System Life Cycle Process Management
Managing compliance across all the phases of SLC
Coordinating with various project teams to ensure compliance
Regulatory Applicability Assessment Report (As required)
SOP (As required)
Master Validation Plan
Requirement Traceability Matrix
Regulatory Compliance Assessment Reports
Error Evaluation and Resolution Report
Final Test IQ ,OQ & PQ Report
Validation Summary Report
Vendor Audit Report
Training the resources as applicable
Polices and procedures including document authoring
Ensuring validation deliverables in alignment with SLC process of client.
Validation Deliverable docs.
Change control doc
Deviation / non-conformance Reports
6.0 Laboratory Informatics IV
Today, laboratory stakeholders expect testing information to be more comprehensive and to flow faster and more securely than earlier, both to satisfy the needs of external clients and to improve internal operations by managing the laboratory’s inherent complexity. Laboratory informatics — the specialized application of information technology to optimize laboratory information management — is essential to deliver information in timely fashion and in standardized electronic formats. In addition, although electronic information management may not always be cheaper than manual alternatives, it reduces errors, reduces dependency on one-off processes that are difficult to maintain long-term and promotes uniformity and agility in the laboratory. In short, laboratory information technology (IT) services are now a mission-critical component of many organisations. The brave new world of laboratory informatics represents a clear break from the past, when laboratories had complete control over their information management activities. Instead, a new information management model has been widely adopted by government jurisdictions.
SciInformatics, we help you to establish a strategy to fulfil your dreams in achieving Paperless Laboratory environment. With our "LAB 4.0" vision and allied services will help you to establish a digital paperless quality environment in the shortest possible time frame.
What is there in LAB 4.0?
Quick health check of Laboratory
Laboratory Audit Report
APO (Application Portfolio Optimization) Service
Comparative Scorecard Report of Lab Automation product based on Lab Audit Report
Assist to prepare RFP
Assist to select Lab
Implements the solution / package
Business Process Re-engineering Study
Configuration/customization as per BPR
Testing the solution as per regulatory guideline
Legacy Data Management
Integrated Report Writing
Analytical Instrument Connectivity
Enterprise Software Interfacing
Application Maintenance & Support
Customization and Configuration of Lab Informatics product along with new report
Support to version upgrade of Lab Informatics product
Support to roll out lab Informatics product to various locations.
Support to technically / functionally manage Lab Informatics product
Onsite / Offshore support at various time zones
SLA driven issue resolution mechanism
Application Validation Service
Risk based SLC approach Computer System Validation
Expertise in GAMP 5 approach
Manufacturing Process Validation
Design SOPs,Protocols and Reports
Qualification – IQ / OQ /PQ
Prospective /Retrospective / Concurrent Analysis
Validation testing & Verification services
Paperless Lab 4.0
Reduction of paper work: acquiring and manipulating data electronically is faster than paper-based processes.
Increasing efficiency: electronic data can be shared more easily and quickly, allowing decisions to be made faster than on paper.
Speeding sample throughput: electronic data acquisition and manipulation allow work to be completed faster and goods to be released to market earlier.
Automating regulatory compliance: 21 CFR Part 11 compliant systems can have the same or better level of compliance, but are generated automatically.
Reducing cost: doing the same work with fewer resources, or more work with the same resources.
Electronic records and electronic signature regulation (21 CFR Part 11): The original request from the pharmaceutical industry was for a regulation to allow the use of electronic signatures to take advantage of technology. This gives the legal basis for the use of electronic signatures, but the issue is that the underlying process is still paper-based.
Electronic submissions: allow faster review and approval of dossiers.
With the publication of the Part 11 Scope and Application Guidance by the FDA, the regulatory pressure of 21 CFR Part 11 has abated somewhat.
However, the business drivers for working electronically have increased. The pressures are:
faster time to market with both R&D and manufacturing
cost reduction: reducing time to release
efficiency and effectiveness of the analytical laboratory
speed of decision making.
If you are interested in working with us then please drop us a line, we would love to hear from you.