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Hurley Consulting offers clients a broad range of consulting expertise together with comprehensive contract research services.  Our services range from nonclinical assessments, clinical trial design, data analysis, regulatory strategy and submissions, to outcomes research, reimbursement strategies, and marketing assessments.  We unite the strategy, planning, and analytical expertise needed for product development and/or evaluation of business opportunities.

Strategy &
Consulting
   CRO & Submission Services

Project Evaluation &
Development Plans


Nonclinical Assessments and Program Management

Pharmaceutical Technology E&T and Management

Regulatory Affairs

Study Design

Data Management and CDISC Dataset Preparation & Validation

Statistical Analysis

Quality Assurance

Legacy Project Evaluation and File Organization

Pharmacovigilance

Electronic Compilation & Submission

 


Regulatory Affairs


The development process is continuously evolving. Successful project support demands scientific expertise, industry experience, inherent flexibility, close attention to detail, and increasing technical requirements to produce electronic submissions.

We can work with the sponsor to prepare development plans to meet marketing objectives and regulatory requirements.

Using the sponsor's style guide and requirements for electronic submissions, we can prepare reports and summary documents in accordance with ICH and FDA guidelines and requirements.

We can compile, validate, and electronically submit documents to FDA through the Electronic Submission Gateway (ESG).

We can collaborate with the sponsor to review and evaluate data in the context of health authority regulatory requirements.

If requested, we can represent sponsors in regulatory negotiations and health authority meetings.

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Quality Assurance


Product development and support for registered products requires a high standard of Quality Assurance and Compliance.

The preparation and review of documentation, verification, and auditing is essential for successful commercialization. In addition to performing independent Quality Assurance and auditing services for sponsors, we design and implement specialized training programs in these disciplines. Our internal educational activities extend to training in the general product development process and in regulatory affairs and compliance activities.

Document and
Documentation Review, Verification & Auditing
  Specialized Training in Product Development & Regulatory Affairs
• Drug Supplies and Packaging
• Analytical Assay Procedures
• Protocol Compliance
AssessmentsDatabase Audits
Regulatory Submissions
• GXP
• DEA Compliance Issues
• Site Audits
• Drug Development Process
FDA Advisory Committee
Presentations• GMP, GLP, GCP Regulations
• Science and Technology
FDA Negotiations
• Quality Assurance/Auditing

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Project Evaluation & Development Plans


A successful product development program begins with a comprehensive understanding of the project and the goals and objectives of the sponsor.

Whether the project is an internal development project or an in-licensing opportunity, decisions are based on a rigorous evaluation of the available data. Development of a strategy for execution, and identification of any additional information required, is a core competence at Hurley Consulting. Our expert multidisciplinary staff can design any additional studies required and provide the support needed to successfully complete the program.

Due Diligence   Development Plans
• Product Portfolio Analysis
• Licensing and Acquisition
Evaluations• Clinical Assessments
• Nonclinical Assessments
• Risk Benefit Analysis
• Safety Assessment
• Identification of Key Success Factors• Profiling Strategies
• Positioning Strategies
• Regulatory Strategy
• Competitive Analysis

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Study Design


Design of studies and identification of methods to efficiently measure, collect, and analyze nonclinical and clinical data.


• Protocol Design/Review
• Sample Size Determination
• Statistical Methodology
• Statistical Analysis Plan (SAP) Development  paradigm

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Nonclinical Assessments &
Program Management



We offer pharmacology and toxicology expertise using in house resources and senior staff experience.

The development requirements are continuously evolving and successful project support demands scientific expertise, industry experience, an inherent flexibility, and a close attention to detail.

Evaluation of nonclinical data needs with respect to local health authority regulations, ICH guidelines, marketing/reimbursement goals, and specific regulatory agency requirements.

Areas of Expertise   Development Programs

• Pharmacology
• Toxicology
• Pharmacokinetics/Toxicokinetics
• ADME
• In vitro/In vivo Metabolism
• Bioanalytical Laboratory Selection
and Oversight

• Detailed Plans and Protocol
• Outlines Safety Assessments

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Legacy Project Evaluation and File Organization


Complete analysis of all existing data, an evaluation of database status according to current regulatory requirements, and a strategic plan for database fulfillment.

Ensuring that information is current and appropriate is an important consideration to minimize product risk, especially in regard to legacy products, the acquisition or divestment of products, or to support U.S. registration. Potential product risks include recalls, out-of-stock situations, or regulatory sanctions, and can provide key data for commercial decision-making. The documentation of the review provides an administrative and legal record to support decisions; can identify problems and remedies; can serve as a reference guide for other reviewers; and, it provides a concise technical information source for Regulatory Affairs, Quality Assurance and Quality Control and other disciplines as needed.

CMC Information   Compliance Assessment
• Manufacturing and Testing Facilities• Raw Materials, Purity, and Methods Validations &Specifications• Process Controls
• Container and Closure Systems
• Stability and Batch Data
• Outer Packaging Labels
• Environmental Considerations

• Status of Legal/Regulatory
Actions for the Sponsor or the Subcontractors Referenced inthe Proposed Submission • Pending Compliance Issues
(e.g. 483s, Warning Letters,
Establishment Inspections Reports, etc.) • CMC Documentation
Review/Change Control – Site Changes – Manufacturing Process (Active and Product) – Analytical Methods (Active and Product) – Test or Process Equipment • Outstanding Reports, Protocols Referred to in theDocuments

Regulatory Files and Correspondences Organization

Submissions
• Health Authority Correspondence
• Application Summaries
Annotated Labeling

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Pharmaceutical Technology


Strategies for evaluating and transferring analytical and formulation technologies.

• Analytical Method Selection, Validation, and Transfer
• Formulation, Evaluation, and Selection
• Stability Program Design
• Design of Method and Process Validation Studies
• Manufacturing Process Transfer
• Process Operations Analysis


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Data Management


Creation of CDISC compliant analyses datasets (ADaM) and study data tabulation model datasets (SDTM). Data entry, review, and presentation of trial data using a validated data management system with an electronic audit trail.

Our experienced programmers and statisticians are expert in performing data integration, data management and statistical analysis services. All our services are performed on validated data management systems with electronic audit trail.

Data can be taken at any stage in the process.

Database Integration   Data Management

• Prospective and Retrospective
Integrated Database Creation and Data Consolidation (“Meta Database”)• Adverse Event, Medical History,
and Concomitant Medication Coding Standardization Across Trials• Database Validation and
Documentation

• CDISC Dataset Preparation and Validation• QA/QC Datasets
• Study Design Tailored Consistency Checks• Data Clean-up

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Statistical Analysis


Statistical analysis services in close cooperation with
the sponsor.

• Statistical Analysis Plan Development
• Safety and Efficacy Analyses
• Data Interpretation and Reporting
• Recreate SAS Programs for Legacy Projects

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Pharmacovigilance


Experienced and timely reporting based on SOPs.

• Integration of Nonclinical and Clinical Results
• Expertise in Multiple Adverse Event and Concomitant
Medication Dictionaries Early Identification of Trends
• Coding Review

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Electronic Compilation & Submission


Our electronic compilation and submission processes encompass all steps from document preparation, processing, and organization, through publishing, QC and validation, submission to FDA, and life cycle management.

Our processes ensure these regulatory requirements are met:

• Organization and XML backbone using eCTD specifications for
global submissions • eCTD study tagging files
• Module 1 regional information
• Software version compatibility
• Bookmarking and hyperlinking
• Document granularity
• Document
- Font and margins- Page size, orientation, and numbering - Properties, security, and indexing • File format, file name, and file size

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25 de forest avenue | summit, nj 07901 usa | phone: (908) 273-8490 | fax: (908) 273-2670 | solutions@hurleyconsulting.com