Services
Clinical Trials and Data Management

Clinical Data Management is a key business process in drug discovery lifecycle. Effective CDM ensures drastic reduction in time, from development to market, for all phases of clinical research. We have a team of experts who live their projects zealously with meticulous attention to the details to generate reliable results in clinical data management.

• Clinical Study Reports (CSRs):

• Case Report Form (CRF) Design.

• Final Trial Reporting.

• Site Initiation, Monitoring and Closeout.

• Database Design and Development.

• Data Entry and Reconciliation.

• Clinical Data Coding.

• Multiple Data Collection Choices: Fax, Paper, EDC. More Info

Biostatistics and Statistical Programming

ADI provide comprehensive Biostatistics and Statistical Programming services for all phases of clinical research and across a wide range of therapeutic areas.We have expert team of biostatistician’s with proficiency to keep your requirements in clinical study protocol development, statistical planning and data review, statistical analysis, and statistical report preparation.Our Biostatistics and Statistical Programming services include:

• Clinical Study Protocol Development.

• Statistical Planning and Data Review.

• Statistical Analysis per Protocol.

• Statistical Report Preparation. More Info

Medical and Scientific Writing

Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely.

ADI provides a wide range of high quality writing services for pharmaceutical, biotechnology and medical devices companies. We have a team of qualified and well experienced medical writers who will provide you a wide range of scientific, clinical and regulatory documents that meet the high demands of the drug regulatory process and allowing you to focus on your core competency areas.

ADI has thorough understanding of regulatory guidelines such as ICH (GCP), EMEA & FDA guidelines regulatory or publishing processes. ADI medical writers with their qualifications in medical, pharmaceutical and other life science subjects, and their experience across therapeutic areas will provide you a high quality reports and documents for regulatory submissions, publications in peer-reviewed medical journals besides effective marketing communications. More Info

Pharmacovigilance

• Collection, collation and compilation of AE/SAE reports from the marketplace.

• Adverse event (AE) and serious adverse event (SAE) narrative writing /data entry, logging, tracking, coding, assessment, case processing and follow-up

• Generation of safety data reports (SDRs)

• Establish database systems and standard operating procedures (SOPs) for each product to be monitored.

• Adverse Event, Serious Adverse Event (SAE) data collection and analysis

• Protocol design and implementation of post-authorization safety studies.

• MedDRA Coding

• Clinical assessment reports of completed studies.

• Adverse event (AE) and serious adverse event (SAE) evaluations

• Analyze data to identify early signals proactively identifying safety issues.

• Search and evaluation of scientific literature (reports of published studies and studies on the product safety)

• Preparing Annual Safety Reports (ASRs) & Periodic Safety Update Reports (PSURs)

• Electronic Safety Reporting according to ICH E2B. More Info