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Enterprise and local scale, RFI and early vendor assessments, requirements gathering, use cases elaboration, demonstration scoring tools and methods, RFP creation, budgeting and financial assessments, project decision support tools

Leveraging best practices such as ITIL and "follow the sun" support structures, extensive technology partner network, level 1, 2 & 3 support, early adopter user training, roll out hyper care, BAU support and knowledge base creation

zifo - software as a medical device companies

SaMD validation strategy, IQ, OQ, PQ development and qualification, software validation execution and regulatory reporting across SaMD regulations

Bidirectional translation of biomedical knowledge from the early research laboratory, through development and manufacturing to clinical & patient-oriented and population-based research

Program and Project scale, AGILE to WATERFALL and all the different connotations between, project scoping and resource planning, kick-off and project delivery, reporting, finalisation and closing

RNA-seq, scRNA-seq, or epigenome (e.g. ChIP-seq, Methylation sequencing) NGS or array-based, NGS-based analysis confirmation of genome edits at a targeted or genome-wide level, sgRNA design optimisation

Machine Learning (ML) and Artificial Intelligence (AI) model development, integration and management to support scientific decisions and analysis.

16s/ITS Metagenomics & Meta-transcriptomics, pre-processing of raw data, dereplication of sequences and chimeric reads removal, OTU picking, Quality filtering, taxonomical classification

Master Data Management (MDM), Semantics and Data Enrichment can help maximise data value, trust in data and support the FAIRification of data assets and digital transformation.

Security, authentication, bandwidth, latency, data formats, and automation implications of robotics, automation, sensors, and instruments in the scientific lab

Instrument validation strategy, IQ, OQ, PQ qualification, risk-based approaches, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all analytical instrument hardware platforms

Early Pharmacology, ADME, Assay Automation, PK/PD, Assay Development & Validation, Bioanalysis, Inventory Management etc. and the linked regulatory aspects of GLP and IND/NDA/BLA creation support.

zifo - graph data services

Generating, transforming non-graph data, and graph data storage platforms like GRAKN, NEPTUNE, NEO4J etc. alongside ontology definition & management supports interoperable and reusable data.

Go Live planning and execution, end-user & super user training, user support, drop-in clinics, hyper care, knowledge base creation, Level 1, 2 & 3 support for any scale rollouts, small, large, global, multisite etc.

Exome and Whole Genome Sequence (WGS) variant calling and genome-wide association studies bioinformatics and data visualisation support

Spatial multiomics integration, Next Generation Sequencing (NGS), array based gene expression analysis, bulk and single-cell RNA-seq, epigenetic data integration, spatial transcriptomics.

Bioinformatics supporting genome-wide landscape of modifications such as DNA methylation, DNA-protein interactions, chromatin accessibility, histone modifications etc.

ecrf setup - zifo - scientific informatics

Edit checks development, RTSM, data mapping, and migration, ePRO, SAE, pregnancy & other reports, data exports, therapeutic area-specific standards

Effective systems integration, networking, deployment, upgrade and maintenance in public/private cloud using "code" to deploy is now commonplace in scientific informatics environments.

ERP, Registration, Inventory, ELN, LIMS integration, laboratory instruments & robotics, project planning & lab audit tools, integration layer technology, instrument data standards (ADF, AniML, SiLA etc.), tech blueprints

Data modelling, plumbing, wrangling, transformation, management, and enrichment all support Machine Learning (ML) & artificial intelligence (AI) as need good quality data to work well.

data integrity company - zifo - scientific informatic company

CDM meeting 21CFR Part 11, EUANNEX Part 11 and GDPR, experience with numerous data analysis/review tools and processes suggested by GCDMP

Data Extraction and Wrangling - Zifo data extraction services

Extracting data from and transforming to alternate formats including graph data structures like RDF, special structures like ADF etc to support loading to data lakes, warehouses for reuse and data FAIRification

Custom architecture, design, build, test, web & cloud, visualisations, JAVA, Python, C++, JavaScript, REACT, AJAX, automated testing, microservices, AWS, GCS, AZURE, Hadoop, SPARK, GRAKN, SQL, Docker, Kubernetes etc

CSV validation strategy, IQ, OQ, PQ development and qualification, risk-based validation, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all lab software platforms e.g. CDS, EDC, ELN, LIMS, in the cloud and on-prem

CMC - product development company

Aggregating and ensuring the regulatory integrity of information for specifications, manufacturing process control parameters, stability parameters and analytical test variance data.

Cloud to Cloud and Cloud to On-Prem system integrations, security, performance and ongoing support are foundational to modern informatics architectures.

On-premise infrastructure to a cloud infrastructure requires planning, iterative migration, new skills development around TechOps and DevOps, and dedicated managed services to be successful.

"Always on", end-user support, proven scale, quality, processes and knowledge of scientific applications have a measurable impact on end-user efficiency, satisfaction and application downtime.

Cloud Architecture & Support - digital transformation services

Architecting, development and managed services on the major providers AWS, AZURE, GOOGLE, on-prem systems integrations, DevOPs and TechOps.

clinical trial protocol design - zifo - scientific informatics company

Objectives/endpoints definition, schedule of events, sample size optimisation, statistical analyses, operationally feasibility, medical writing, regulatory submissions

clinical trial data management companies - zifo scientific informatics company

SEND and CDISC data standards for NDA, ANDA, and BLA submission support.

Pharmacology, ADME cascade automation, PK study design, resource management, data acquisition, Bioanalysis, PK modelling and regulatory submissions

clinical trial monitoring services - zifo

Data management plan, central monitoring, data acquisition, ongoing data review and query management, lab data setup and management, SAE reconciliation, medical coding of terms and events, database lock

clinical data management services - zifo

CDASH / SDTM / ADaM / TLG standards, therapeutic area-specific assets, SDTM and Define-XML tools, data management dashboards (remote & statistical monitoring), online data management binders for EDC/CRF setup

Stakeholder and end-user engagement, requirements and vision capture, change readiness assessment, decision making and consensus building, communication planning and program success monitoring.

Manipulation of biology at the 'Omic level and its downstream effects uses many different techniques such cloning, plasmid design, cell transfection and protein/product production.

AS-IS process mapping, TO-BE state definition, application landscape & data landscape mapping, instrument and lab audits, requirements capture, FRS creation, FAIR assessments & dashboarding, data maturity assessments and analysis

biometrics companies - zifo rnd (scientific informatics company)

CRF design, sample size determination, creating statistical analysis plans, generating tables, listings and graphs, interpreting and reporting of results in SAS, Phoenix, R, JMP and other platforms.

Ontology definition and governance in commercial and open-source platforms alongside deep domain and technical knowledge to support your FAIR and semantic data journey.

Assay development and validation, instrument data acquisition and integration, regulatory and QC data reporting, lab inventory and metrology, workflow automation and validation

clinical trial services - zifo (scientific informatics company)

Reporting through pre-defined formats like MedWatch, CIOMS, and sponsor validated specific formats, EDC on-prem automation solutions