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.
Meet the Founder/Managing Director of 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—expanding its offerings to include Regulatory and Medical Writing, Inspection Readiness, and Quality Management. This growth was fueled by Marilyn’s deep expertise in clinical operations and regulatory strategy, as well as the trusted network of seasoned professionals she built over decades of global experience in the biotechnology and pharmaceutical industries.
Under Marilyn’s leadership, CRS became a dynamic hub of cross-functional knowledge. She brought together a collective of industry experts—many of whom she collaborated with across continents and therapeutic areas—who now contribute their expert insights to projects. Her strategic oversight, combined with her proficiency in dossier development, quality control, and operational excellence, continues to distinguish CRS as a partner of choice for biopharma companies worldwide.
As the life sciences industry evolved, so too did Clinical Research Solutions. What began as a focused venture in Investigational Site and Clinical Program Management has matured into a trusted consultancy known for its adaptability, speed, and unmatched regulatory insight. 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.
Marilyn’s therapeutic area experience spans oncology, immunology, central nervous system, dermatology, infectious disease, cardiovascular, rare disease and many others. Together with her team, she ensures that every program managed by CRS is rooted in scientific rigor, compliance, and patient-centered care.
Marilyn is a respected mentor and trainer, having developed professionals and delivered training materials in drug and device development, process management, and corporate leadership. Whether leading regulatory teams, streamlining clinical operations, or auditing for GXP compliance, Marilyn brings clarity, structure, and strategy to complex challenges.
CRS has consistently anticipated shifts in regulatory expectations, responding with proactive solutions that help clients navigate complex global frameworks and accelerate development timelines. Its team of senior professionals; many of whom Marilyn has collaborated with throughout her international career; provides hands-on leadership in areas such as dossier strategy, compliance assessments and remediation, vendor management, inspection readiness, and efficient, high-quality medical writing.
The company's evolution reflects more than organic growth; it signals a deep understanding of whatit takes to operationalize excellence and deliver with integrity. Today, CRS stands as a partner of choice for companies seeking streamlined processes, cross-functional alignment, and a results-driven approach to bringing new therapies to patients.
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 experienced professionals with industry knowledge and a history of success. CRS offers a wide range of services, including clinical development planning, clinical trial monitoring, medical and regulatory writing for submissions, quality control review, quality management development and implementation, gap analysis, vendor compliance, monitoring, and auditing services.
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
