Clinical Research Solutions
Inquiries: marilynwhite@clinrs.com
Telephone: 781 504 3235
Seasoned Experts in Clinical Research, Medical Communications and Regulatory Writing and Quality Management
Clinical, Regulatory and Quality Experts providing design, planning and implementation of successful industry research to achieve clear results required
for regulatory submission.
About Clinical Research Solutions
Marilyn White co-founded Clinical Research Solutions (CRS) in 2001 with a vision to deliver exceptional Clinical Research Site and Program Management services. As the needs of clients evolved, so did CRS by expanding its offerings to include Quality Management, Inspection Readiness at Sites, Vendors, and Internally, and Regulatory and Medical Writing. This growth was fueled by deep expertise in clinical operations and regulatory strategy, as well as the trusted network of seasoned professionals built over decades of global experience in the biotechnology and pharmaceutical industries.
CRS's expansion has been propelled by the foresight of its founder, Marilyn White, and the strategic contributions of a global network of experts; each bringing specialized knowledge shaped by years at the forefront of biotech and pharmaceutical innovation. It has become a dynamic hub of cross-functional knowledge brought together by a collective of industry experts collaborating across continents and therapeutic areas. Strategic thinking and expertise in clinical development, quality control, and operational excellence, continues to distinguish CRS as a partner of choice for biopharma companies worldwide.
About Clinical Research Solutions
Clinical Research Solutions (CRS) provides tailored solutions for small and medium-sized biotechnology, pharmaceutical, and medical device companies. By collaborating early to understand business objectives and challenges, CRS utilizes its expertise to achieve high-quality, cost-efficient, and market-approved products.
The team includes senior professionals with industry knowledge and success. CRS offers a wide range of services, including:
> clinical design/development > clinical trial monitoring,
> medical/regulatory writing
> regulatory submissions
> quality control review
> quality management
> gap analysis
> vendor compliance,
> GXP auditing
Clinical Development and Operations Consulting
Target Product Profiles
Clinical Development Plans
Protocol Design Consultation
Clinical Operations
Study Start Up Feasibility
Site Selection Investigator Meetings
Site Budgets and Contracts
Clinical Trial Plans
Study Management Recruitment
Data Capture
Risk-based Monitoring
Clinical Oversight Plans
Protocol Design Consultation
Clinical Site and Program Management
Inspection Readiness
Define goals and benchmarks
Review documents
Conducting subject matter expert interviews
Determine/catergorize findings
Teams address findings
Prepare and collaborate with teams
Create storyboard and narratives with teams.
Clinical Personnel Placement
Directors
Fractional
C-Suite | Chief Medical Safety Officers
Program and Project Managers
Clinical Research Associates
Clinical Data Managers
Clinical Scientists
Nonclinical and Clinical Regulatory Writing and Editing
Investigator Brochures
Protocols
Informed Consent Form
Clinical Study Reports
Pharmacovigilance
DSURs
Safety Narratives
Regulatory Writing
Investigational New Drug Applications
Marketing Applications
BLAs, NDAs, MAAs, 501ks
Module Gap Analysis
FDA Meeting Requests
Briefing Books
Health Authority Responses
Post Market Regulatory
PBRERs
PADERs
Editing
Logic
Publication
Science editing
Quality Control
Format and data checks
Medical Communiciations
Manuscripts
Publications
Case Studies
Posters
Patient Brochures and recruitment advertisements
Promotional and marketing material
Product Monographs
Medical Conference Writing
Quality Management
Quality Management System Assessment & Remediation
Ensuring GXP data integrity
Product and process safety
Efficacy and quality per regulations
Compliance Assessments And Vendor Management
Assessment, Selection, Monitoring and Auditing
Contract Research Organizations
Clinical Research Site
Management Electronic Vendors and Laboratories
Internal Auditing/Gap Analysis
Specialize in company merges and acquisitions
Create/Review/Revise
Standard Operating Procedures
Review of internal processes and workflow within and across departments
Data stewardship
Ensure data integrity and compliance by showing transparency and chain of custody documentation.
Guidance flexibility allows for the inclusion of real world evidence, bayesian designs, adaptable designs and data coming from more than one controlled clinical design.
There is a need for chain of custody documentation and data transparency to show data integrity and compliance.
External Auditing
Contract Research Organizations
Clinical Research Sites
Electronic Vendors and Laboratories
Gap Analysis and Remediation
Identify noncompliance
recommend process improvements
Prioritize gaps
Risk based recommendations
Implementation plan
