Services

CLINICAL OPERATIONS

We can perform all stages of clinical trials – from feasibility to final study report – to the highest quality standards.

We have wide therapeutic experience, excellent cooperation with site staff and in-depth knowledge of local requirements. Our core expertise and focus is in the South India, however we are able to cover the whole of Asia and many other countries through our partner CROs. Our resourcing model provides both the flexibility and local knowledge of each country that the study requires.

Monitor plays a significant role to ensure the project success.  As a company commitment to Clinical Research Excellence, we designed the role of our monitors to go beyond, than simply meeting the technical accuracy demanded by the research.

Our CRAs are trained to predict site management issues and proactively develop and implement solutions. CRAs undergo a thorough instructional regimen and are trained. This approach is employed from the earliest stages and throughout the conduct of the clinical study, to ensure the proper flow and responsiveness of the process.

All our monitors are full-time bilingual employees, equipped with laptops and are always available through mobile phones and internet when they are off site.

Whether helping your organization handle an overload of work on a single project or designing a full-service clinical program for your product, Aatrix Biosciences clinical trials management team has experience and knowledgeable staff members ready to assist you.

  • Clinical services custom-tailored to fit your needs.
  • Study document development.
  • CRA management and quality control.
  • Clinical monitoring and site management.
  • Clinical Trial Management System.
  • Investigator meeting planning.
  • Audits and preparation for audits.
  • Training.
  • Patient recruitment and retention strategies.
  • Feasibility studies.
  • Quality training of clinical associates.

 

DATA MANAGEMENT

An effective data management is the principle core for any successful clinical trials. At Aatrix Biosciences, the handling and maintaining of clinical trial data is a major part of our service offering. Our team members have sound knowledge in Medicine background, Biological sciences and also have a good experience in multiple therapeutic areas.
Our team is experienced and exposed in handling both paper and eCRF based studies. More over the team is flexible in adopting to the Sponsor specific tools to manage their data.
The robust SOP’s enable us to be on par with any of the leading players in the industry in terms of Quality deliverables.

BIO-STATISTICS :

We understand the importance of Statistical Analysis in clinical research and therefore we strive to provide quality services and solutions.
To ensure quality, we employ robust SOPs to practices. All our statistical services are based on ICH – GCP guidelines. Our team of knowledgeable and well experienced Biostatistician and Statistical Programmers are dedicated to deliver quality services across a wide range of therapeutic areas and to all phases of clinical trials by emphasizing on process optimization and accelerate timelines while ensuring quality and research cost reduction.

Some of the key areas of support include:

• Power / Sample size estimation
• Protocol preparation
• Mock tables and listings
• Edit check programming for Data Management team
• Analysis dataset generation
• Tables, Listings and Graph generation
• Statistical Analysis
• Interim and Final Report generation
• Validation programming and QC of Reports
• Integrated Summary of Safety and Efficacy
• Statistical Reports

SITE MANAGEMENT

Aatrix Biosciences performs site management services to act as the liaison between the site, the sponsor and the conduct of the study. We do this by continuous communication with every study site, starting with the collection of regulatory documents and continuing throughout enrollment, follow-up and project completion.

Aatrix Biosciences understands that site training is key to ensure proper study conduct, quality data collection and to keep our sponsors’ projects on top of the to-do list.

Our Project Managers and CRAs institute training programs for all site staff to ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and adherence to the protocol as well as timely patient recruitment. We develop effective study protocol tools, newsletters and subject enrollment aids to reinforce site staff training.

Our proven comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. In addition, weekly teleconferences are scheduled with the site throughout the project that allows our staff to review study status, CRF and query completion and assist with protocol questions and any other study related activities to ensure the study proceeds in a timely manner. Aatrix Biosciences ensures all study information is current, prioritized, and available to Sponsors for effective site management.

MEDICAL WRITING

Our medical writing services are based on our extensive experience in the pharmaceutical industry and our commitment to quality, which ensures clear, concise and well-structured documents.

Aatrix Biosciences has a team of experienced medical writers with medical and scientific expertise to provide high quality clinical study documents compliant with ICH-GCP guidelines and regulatory requirements.

From protocol writing to the final study report preparation, our medical writers collaborate with bio-statisticians and project team members to produce comprehensive, submission-ready documents for all stages of clinical development.

All documents are peer reviewed to ensure medical and scientific accuracy and are subjected to continuous quality control to guarantee compliance ensuring high quality deliverable, on-time. We provide medical writing services as part of the comprehensive clinical trial program or as a stand-alone service.

Our medical writers help you in the preparation of the following:

  • Investigator brochure
  • Clinical study protocols
  • Informed consent forms
  • Study assessment questionnaires
  • Patient dairies
  • Clinical study reports – Phase I to IV
  • Abstracts and manuscripts
  • Clinical overview and Clinical Summary
  • DSMB manuals