Desk Search
We do high quality and specialized Desk research for pharmaceutical, biotech, CRO,
medical devices, R&D Companies, Universities, Institutions and Publishers on clinical
research. Our researchers are with proven experience and professional qualifications
in clinical, pharmacy and medical fields. Our search output is delivered in text,
Word, PDF/Tiff or in other database formats as required by the clients.
Data Management
Clinical data management involves the collection, handling, analysis and cleaning
of data to ensure that the quality is acceptable for submission to the regulatory
authorities.
Our 21 CFR Part 11 compliant data management systems ensure quality in clinical
data for analysis. Our persistent effort in quality control and quality assurance
enables us to deal with large amounts of data with high level of accuracy.
We do Paper Data Capture (PDC) from conventional case report forms and Electronic
Data Capture (EDC) through remote data entry. Our in house software and
database professionals work closely with the clinical data managers and the project
team to design a database in the backend and data input screens at the front. Validations
are set up in the data entry work process to ensure the quality data is captured
from the beginning.
Double entry system of KEY-KEY-VERIFY is done to guarantee high level of
accuracy. The Subject Matter Experts are available real-time with the data
entry Specialists to clarify queries and give resolutions to discrepancies.
Services
- Custom database generation and design
- Data receipt, logging and tracking
- Double data entry from CRFS
- Data entry cleaning
- CRF design, production, tracking and review
- Safety data management and review
- Clinical Database closure and locking
- Clinical Data transfer
- Clinical Data quality assurance and quality control
- Discrepancy/consistency checks of medical and scientific data
- Automatic edit checking and query tracking
- Coding of clinical data
- Data validation and review
Statistical Analysis
We have highly skilled and experienced Bio statisticians. They seamlessly work with
the clients in all stages from planning and conducting interim and final analysis
to reporting and developing statistical study designs, analysis methods, and interpretations.
They also ensure compliance with regulatory guidelines.
Data are input, managed, analyzed, and reported in SAS, the preferred format of
the FDA. We also use SPSS and other Statistical tools as desired by the Clients
for statistical programming and analysis. Our statisticians are experienced with
a wide range of study designs across various medical specialties/therapeutic areas.
Services
- Clinical Study Randomization
- Dynamic Randomization
- Sample size estimation
- Statistical Analysis Programming
- Interim/Sequential Analysis
- Periodic clinical data monitoring and safety reviews (DSMB)
- Statistical consulting
- Crossover design
- Data modeling
- Parametric and non-parametric statistics
- SAS, SPSS and Other Software Packages
- Client Customized Datasets
- Data Listings/Tables
- Graphical Data Presentations
Medical Writing
Our Medical writers follow ABC Principle (Accuracy, Clarity, and Brevity) to prepare
the documents for submissions in compliance with all the regulatory standards.
The documents are
- Scientifically and medically correct
- Statutorily right
- Compliant International standards
Services
- Statistical Reports
- Interim and final efficacy reports
- Safety/Data monitoring reports
- Integration of Safety and Efficacy Reports
- Review of medical and scientific reports on post-hoc/exploratory analyses
- Manuscripts and Abstracts
- Manuscript editing for publication
- Graphics and visual representations
|
