RESEARCH INNOVATION, DESIGN AND ANALYSIS

Accelerate your research by design

Specialized Services to Design Cost-Effective Research

Assisting investigators to design research and write protocols that maximize data discovery and reduce overall costs without jeopardizing the integrity of primary and secondary objectives

Early Stage Design and Innovation Services

Design your research with our experienced teams.

Regulatory Affairs Services

Design sound regulatory strategies aligned with the regulatory environment and your research goals.

Biostatistics Services

We assist you in experimental design and statistical methodology to help design your trial for better decision making.

Data Management Services

We can help you design, build and deploy research databases from first patient in to database lock.

Early Stage Design and Innovation Services

CCI facilitates global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management, including consulting services for clinical trial applications, marketing applications, medical devices, medical writing, publishing and submissions, lifecycle management, pre-clinical and chemistry, manufacturing and controls consulting, agency interactions, strategic consulting and intelligence and quality review.

Documenting pharmaceutical quality/chemistry, manufacturing, and controls; obtaining scientific advice and protocol assistance; following the FDA’s Physician Labeling Rule; adhering to scientific guidelines implementing regulatory requirements.

Insight on FDA regulatory environments, smooth transitions from exploratory to confirmatory stages of investigational drugs, expedited submissions for possible acceleration of the developmental process, facilitated approval of applications to conduct clinical trials of new drugs, responses to regulatory body requests for information.

Services

  • Development of clinical research protocols from clinical concept and beyond
  • Assess population dynamics, study design, and statistical strategy to ensure valid outcomes
  • Ensure compliance to ICH-GCP Guidelines
  • Advisory services for development of SOPs

Regulatory Affairs Services

CCI facilitates global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management, including consulting services for clinical trial applications, marketing applications, medical devices, medical writing, publishing and submissions, lifecycle management, pre-clinical and chemistry, manufacturing and controls consulting, agency interactions, strategic consulting and intelligence and quality review.

Documenting pharmaceutical quality/chemistry, manufacturing, and controls; obtaining scientific advice and protocol assistance; following the FDA’s Physician Labeling Rule; adhering to scientific guidelines implementing regulatory requirements.

Insight on FDA regulatory environments, smooth transitions from exploratory to confirmatory stages of investigational drugs, expedited submissions for possible acceleration of the developmental process, facilitated approval of applications to conduct clinical trials of new drugs, responses to regulatory body requests for information.

Services

  • Insight and advice on regulatory environments through development
  • Support for submissions to regulatory bodies
  • Responses to regulatory body requests for information
  • Support for and participation in meetings with regulatory bodies

Biostatistics Services

Biostatisticians provide statistical collaboration by performing the analyses and writing the methods and results sections of manuscripts and answering any questions that arise in the editorial review process. Informal consultations are also available.

The CCI Biostatistics Consulting Service provides support for small, single center studies and multicenter international clinical studies. This support is available to the research community for statistical consulting on issues such as study design, data analysis for protocol development and grant applications, design support for pilot projects and grants and data analysis for, abstracts, manuscripts and presentations. This service provides an alternative for investigators who traditionally may have resorted to finding independent biostatisticians through local resources like the Harvard School of Public Health.

OFFICE HOURS 

Tuesday's 1:00pm-2:00pm | Location 221 Longwood Ave Suite 251

CCI and the Harvard Catalyst Biostatistical Consulting Program offer weekly consultations. No reservation is required, and it is free. Biostatisticians will answer your statistical questions, guide you to more in-depth support, and will be available for both short- and long-term collaborations.

Services

  • Clinical Trial Design and analysis
  • Longitudinal and dependent data
  • Categorical data analysis
  • Generalized linear models
  • Medical imaging
  • Missing or mismeasured data
  • Semiparametric or nonparametric methodology
  • Statistical genetics and computational biology
  • Survival analysis
  • Psychometrics
  • Multivariate data analysis
  • Computational statistics
  • Regression diagnostics
  • Quality improvement
  • Power analysis and design
  • Database design

For a complete list of our Biostatisticians areas of expertise please click here

Data Management Services

CCI Data Management Services is a developing area of support. Our data management team works with investigators to evaluate concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research. Our team can help you deploy a data capture system, design case report form (CRF), set-up and validate your study database, review and verify data, and provide data in a format ready for submission to regulatory authorities through final database lock.

Services

  • Case report form (CRF) design, electronic or paper
  • Database set-up and validation
  • Electronic data capture (EDC) systems implementation and training
  • In-depth quality assessments to identify errors and querying data through final database lock

Ready to move forward?

We can help assess next steps, problem solve, and remove roadblocks holding you back.

Scroll to Top