Life Sciences Service Offerings:
Our team offers the Life Sciences Industry the full pallet of the Quantensprung Group service offerings.
Additionally, the Quantensprung Group provides service offerings specific to the Life Science and Medical device Industries:
Project and Program Management and Technical Leadership Providing End to End Fully Integrated Solutions For your GXP Needs
The Quantensprung Group
Quality Systems Development and Quality Assurance:
The Quality System (QS) is the infrastructure that defines a company’s ability to provide consistent, compliant, and high-quality deliverables by documenting processes, procedures, and responsibilities for achieving quality objectives. All operations are governed by the QS and oversight of the system and processes by QA is integral to whether a company is successful. We have the expertise to assist companies in establishing a phase-appropriate QS and ensure appropriate oversight of those systems.
Chemistry Manufacturing and Controls-Technical Operations Commercialization:
One essential requirement for product approval is the ability to manufacture commercial products after completing clinical scale CMC development activities. Consultants have a proven track record of ensuring all CMC requirements are in place for production operations that meet clinical development expectations as well as approval inspection expectations.
Regulatory Affairs and Regulatory Operations:
Our experts are experienced Regulatory Affairs professionals at both strategic and operational levels. Consultants provide guidance and support for regulatory development activities and Health Authority meetings and provide regulatory writing and submission support when needed. We also provide high-quality eCTD formatted publishing and
e-submission services.
Discovery and Preclinical Operations:
Our consultants are well-versed in early-stage discovery and preclinical research and have a broad background in preclinical development. With this experience and thorough understanding of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP), consultants support by developing sound scientific studies, robust reports, and ensuring traceability and data integrity, ultimately to ensure that the preclinical development package supports the planned clinical trials and NDA/BLA submission.
Strategic Consulting:
Expert Consultants have a broad range of experience in developing successful strategies encompassing research, development, clinical trials, and commercialization, resulting in speed to market. Through our proprietary Quality System, they can assess the complete product lifecycle and identify the strategic execution elements necessary for product approval, assist in specific areas for acute issue resolution (i.e. environmental contamination in a manufacturing suite, 483/warning letter responses, and resolution, to consent decree remediation), or can provide targeted guidance for continuous improvement within the QMS.
Clinical Programing
The Quantensprung Group acknowledges our Clinical Programing team that helps clients accelerate cycle time to clinical cut-off, and submission and increase learning events enabling more Dry Runs for break-through clinical innovation.
Leveraging proprietary software accelerators, our team not only provides the resources to do the heavy lifting, we utilize state of the art technology empowering our clients’ significant competitive advantage.
Below are more details about the offerings:
Clinical Programming Overview
Our clinical statistical programming services encompass comprehensive end-to-end study reporting, including Biostatistics Data Review (BDR), Interim Analysis (IA), Data Monitoring Committees (DMC), Clinical Study Reports (CSR), and Integrated Summaries of Safety and Efficacy (ISS/ISE) submission programming. We specialize in therapeutic areas such as oncology, offering robust support for regulatory rapid response and specialized programming, including biomarker and pharmacokinetic/pharmacodynamic (pk/pd) analyses.
We excel in Standard Management, covering CRF design, strategy, programming, and compliance. Our expertise in CDISC includes P21 validation, deep knowledge of SDTM/ADaM and regulatory guidelines, and SDRG/ADRG creation. Our team has solid experience with SAS and R programming, particularly with oncology endpoints, pain, inflammation, and biomarkers, including static and interactive R graphics. We also provide comprehensive support in SOP creation and compliance for statistics, programming, and data management.
Additionally, we offer advanced services in SCE development, covering requirement gathering, specification creation, and AWS cloud components, as well as leveraging GenAI for protocol/SAP creation, CSR, and programming validation. As PHUSE members, we engage in digital health technology around GenAI, and provide business consulting for the next generation design and implementation of statistical computing environments.
The Quantensprung Group acknowledges our Clinical Programming team that helps clients accelerate cycle time to clinical cut-off, and submission and increase learning events enabling more Dry Runs for breakthrough clinical innovation.
Leveraging proprietary software accelerators, our team not only provides the resources to do the heavy lifting, we utilize state-of-the-art technology empowering our clients’ significant competitive advantage.
Below are more details about the offerings:
Clinical Programming Overview
Our clinical statistical programming services encompass comprehensive end-to-end study reporting, including Biostatistics Data Review (BDR), Interim Analysis (IA), Data Monitoring Committees (DMC), Clinical Study Reports (CSR), and Integrated Summaries of Safety and Efficacy (ISS/ISE) submission programming. We specialize in therapeutic areas such as oncology, offering robust support for regulatory rapid response and specialized programming, including biomarker and pharmacokinetic/pharmacodynamic (pk/pd) analyses.
We excel in Standard Management, covering CRF design, strategy, programming, and compliance. Our expertise in CDISC includes P21 validation, deep knowledge of SDTM/ADaM and regulatory guidelines, and SDRG/ADRG creation. Our team has solid experience with SAS and R programming, particularly with oncology endpoints, pain, inflammation, and biomarkers, including static and interactive R graphics. We also provide comprehensive support in SOP creation and compliance for statistics, programming, and data management.
Additionally, we offer advanced services in SCE development, covering requirement gathering, specification creation, and AWS cloud components, as well as leveraging GenAI for protocol/SAP creation, CSR, and programming validation. As PHUSE members, we engage in digital health technology around GenAI and provide business consulting for the next generation design and implementation of statistical computing environments.
Clinical Safety and Pharmacovigilance:
Having robust Quality Systems and QA oversight ensures clinical trials are planned with success and efficiency in mind. Consultants provide specific clinical operations services including, but not limited to clinical project management, development of SOPs and other clinical documents, monitoring and oversight, as well as data management and SAS® programming services. Subject matter experts are also experienced in SAE processing, narrative authoring, and review, and assessment and oversight of safety & pharmacovigilance (PV) vendors, while other drug safety and PV assistance are available through strategic partnerships.
quantensprunggroup.com 