Clinical Development Plan

Our staff has the scientific background coupled with the regulatory experience to assist you with the preparation of your Clinical Development Plan.

  • Regulatory strategy consultation
  • Clinical protocol development
  • Sample size and power calculations
  • Evaluation of bio / surrogate markers for early demonstration of efficacy and safety.
  • Informed consent in adherence with FDA guidelines

Experience includes Quality of Life, Bioequivalence, Bioavailability and Meta-analyses

Site Recruitment and Management

Our database of key investigators and opinion leaders, organized by therapeutic and geographic area, will expedite your site screening and selection process. Once sites are selected for participation, ClinSmart offers a full range of site initiation and management services to ensure your study runs smoothly.

Services include:

  • Site telephone interviews to determine interest, availability & expertise
  • Preparation of letters of confidentiality, conduct qualification visits and formal evaluation reports
  • Investigator Meeting support
  • Orientation / initiation visits, including verification and collection of regulatory documents and discussion of trial parameters
  • Interim monitoring visits, including source data verification, IRB / SAE document review and CRF corrections
  • Ongoing trial site management
  • Close-out visits, including final binder review, final drug accountability / return and review of study documentation.

In addition to the traditional monitoring activities, ClinSmart also offers internet-based remote site monitoring. This reduces the number of required site visits and allows us to monitor site performance and documentation 24 hours per day, 7 days per week.

Data Management

ClinSmart employs traditional methods as well as internet-based solutions to prepare your CRF and ultimately manage the collection, QC and QA of the data during the trial.

  • CRF and eCRF design
  • Data management plan development
  • Data collection system development, including database design, programming, validation and system maintenance
  • CRF processing, including tracking, double data entry and verification
  • Electronic data collection
  • Data cleaning / Quality Assurance, including edit checks, query resolution and documentation of corrections
  • Reconciliation of external data
  • Medical coding

Biostatistics

Data, processed rapidly and with accuracy, becomes information upon which conclusions are based. ClinSmart utilizes the appropriate tools to evaluate information on an ongoing basis thereby allowing the availability of statistical results shortly after LPLV.

ClinSmart will:

  • Develop the Statistical Analysis Plan
  • Provide sample size determinations and power calculations
  • Perform statistical analysis, including SAS dataset creation, SAS program development and all required testing and validation
  • Create a complete data package with validation of tables and listings
  • Provide scientifically sound interpretation and reporting of results
  • Provide clients with remote access to data for analysis

Regulatory Affairs

The Regulatory Affairs team at ClinSmart works closely with our clients to prepare for regulatory submissions from the time of project initiation through application submission and approval.

Services include:

  • Comprehensive review of your clinical program for input and guidance on regulatory strategy
  • Organization of Pre-IND submission / end of Phase II meetings
  • IND & NDA assembly, submission and management
  • Agency compliant electronic or paper-based submissions for both US and non-US regulatory environments (FDA, EMEA, MHLW)
  • SOP preparation and adherence
  • Auditing and Quality Assurance
  • Regulatory agency liaison
  • Evaluation of manufacturing sites for regulatory compliance

Medical Writing

ClinSmart’s experienced team of medical writers will prepare regulatory documents in accordance with the specific guidelines and standards as recognized by the industry and FDA. Our team can assist you with:

  • Study reports
  • Integrated clinical trial reports
  • Scientific posters and papers
  • Clinical manuscripts to support marketing and journal publications

Drug Safety and Pharmacovigilance

Timely and accurate information is critical when making decisions affecting human life. ClinSmart offers both traditional and internet-based solutions to expedite the reporting and tracking of adverse events / serious adverse events.

Services include:

  • Development of safety databases
  • Coordination with regulatory and clinical stakeholders
  • Medical review and coding of Adverse Drug Reaction Reports
  • Risk signal detection and evaluation
  • Action Plan development for safety risks
  • Narrative writing
  • Regulatory reporting and submissions – CIOMS, MEDWATCH, PSURs, expedited reporting

Patient Registry

ClinSmart’s proprietary and customizable technology assists with new product launches as well as post-marketing support programs to assess performance, outcomes, safety profile confirmation and market segmentation.

ClinSmart will support your registry needs through:

  • Strategy development
  • Registry protocol development
  • eCRF development, including Quality of Life questionnaires
  • Physician recruitment and management
  • Statistical evaluation of economic and clinical outcomes
  • Data collection and management
  • Manuscripts for publication

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