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About us
Services
Registration Dossiers
SPC
Preclinical Overview (CTD)
Clinical Overview (CTD)
Package Inserts
Patient Leaflets
Medical Writing
Contact us
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MEDICAL
WRITING
Emphasis on quality,
clarity and adherence to schedules are our hallmarks. We can prepare
documents in accordance with your company template and style guide (if
available), or use our own templates.
Regulatory Writing
We provide regulatory writing and dossier preparation for
pharmaceutical drug applications . We
are well versed with the current CTD format. We have prepared
ready-to-use templates for preparation of dossiers as per the CTD
guidelines. We offer the following regulatory writing related services :
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Non-clinical
Summary |
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Clinical
Summary |
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Compilation
of non-clinical and clinical data for drug applications |
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Periodic
Safety Update Reports |
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Investigator's
Brochures |
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Product
Monographs |
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Validation
Reports |
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Patient
Information Leaflets |
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Summaries
of Product Characteristics (SPC) |
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Package
Inserts |
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Summary
Basis for Registration Application (SBRA) |
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Material
Safety Data Sheets (MSDS) |
Clinical Study Reports (CSRs)
Our team has considerable expertise in writing
clinical study reports. We are equipped in designing clinical studies,
preparation of protocols, data entry, statistical analysis and preparation of the final
report.
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Designing Clinical Studies taking into
consideration i)
Methodological issues, such as the experimental design, optimal
efficacy and safety variables and
ii) Statistical issues, such as the determination of sample
sizes, the use of appropriate statistical tests, and the adjustment
for confounding variables
Preparation of Clinical Study protocols which
include background information, study objectives, study design,
selection and withdrawal of subjects, assessment of efficacy and safety, statistics,
ethics, data handling and record keeping.
Preparation
of Investigator’s brochure incorporating confidentiality statement, signature page,
summary, physical & chemical properties,
nonclinical Pharmacology, PK and product metabolism in animals, toxicology,
effect in humans., PK and product metabolism in humans, safety
& efficacy and marketing experience.
Data
entry in
Excel sheets for analysis
Statistical
analysis of data
Preparation
of manuscripts and abstracts from the full CSRs
Preparation of Clinical Study Reports which
include title page, synopsis,
table of contents for the individual clinical study report, list
of abbreviations and definition of terms, ethics, investigators
& study administrative structure, introduction,
study objectives, investigational plan, study patients,
efficacy evaluation, safety evaluation, statistical analysis,
discussion & overall conclusions, tables, figures & graphs
referred to but not included in the text, reference list and
appendices.
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Literature Searches
We have access to a comprehensive range of online databases, including MEDLINE and EMBASE, as well as a number of electronic journals and other online resources, and can perform a literature search on your
behalf.
We can handle searches of all sizes, providing you with the level of service that you require. Our attention to detail ensures that you receive a thorough, accurate, and representative coverage of all the available literature.
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