Technological advancements and customer expectations have created a demand for a new generation of medicines. However, the process of developing new drugs encounters significant challenges in the form of costly discovery, clinical development, regulatory compliance, sales and marketing effectiveness and customer support.

Benefits to you when working with Insigma:

• High-performance systems to handle the vast amount of data processing and computational rigor required
• Resources to not only find the right molecular fit but also separate out the unfit ones
• Ability to automate or update systems to address the challenges of reduced clinical cycle times and changing regulatory compliance structures
• Robust data collection and analytics for the research phase, especially quality data-management systems that make the process simpler and faster
• Pre-clinical simulation services using various algorithms and software tools
• Knowledge-management tools to prevent hindrance of idea flow in distributed laboratories, thus causing a delay in the drug discovery process
• Ability to maintain data integrity and security at the clinical development stages
• Regulatory reporting structure
• Rigorous audit process covering the entire drug discovery process (covers adequacy, maturity, physical infrastructure, information security, and intellectual property protection)
• Access to China market - Some of our clients also enjoy a competitive advantage through our large distribution network in China, making us a perfect partner for pharmaceutical companies seeking to enter the China market with their products.
• Global talent pool, many of whom have PhDs in healthcare and have deep understanding of all the nuances, risks, and leverages to use in developing new drugs
• Our cost optimization framework
• Expertise in the following systems: Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN), Clinical Trials Data Management Systems (CDMS), Scientific Data Management System (SDMS) and Compound/Biological Registration Systems.

One of the major challenges in the industry is the drug development cycle time. Approximately 50% of this cycle time is consumed at the clinical trials stage. We boost efficiencies at every stage to accelerate the process so your organization can have more drugs in the pipeline.

Services include:

• Research tools and application development – data warehousing, data analytics and data mining services; genome analysis tools and algorithms; application development and maintenance of Bioinformatics and Chemo informatics systems; visual analytics

• Pre-clinical simulation – In-Silico simulation, In-Vitro simulation

• Knowledge management – portals and wikis, enterprise search, IP and research reports

• Clinical trials management – clinical supplies management, investigator and site management, patient life cycle management, adverse event monitoring and management

• Clinical data management and analytical services – hosting, secured database design and build, protocol adherence and standard adoption, development and validation of SAS programs, statistical reporting safety and quality control, data migration

• Compliance services – MedDRa coding, risk management strategy

• Medical writing – protocols, ICSR, safety specifications; end-to-end regulatory documentation – clinical trial reports, clinical subject narratives, etc.; scientific literature services

• Audits

• Consulting – GxP compliance – regions (USFDA, EMEA), gap analysis, compliance change management, implementation, testing compliance adherence, training, document management