We offer an effective and reliable range of clinical operation services to our clients spread all across the globe. The team consists of :

• Clinical Research Associates
• Assistant Managers
• Project Managers

The core responsibility of our clinical operation group is to monitor sites to ensure collection of clinical data that is ICH GCP, Protocol and any other applicable guideline compliant. Equipped with masters in life sciences and Pharmacy, team members are trained intensively in ICH-GCP guidelines, Roxaane's and other applicable SOPs, and Protocol before being assigned a study.
  
Roxaane Services Includes :

• Feasibility assessment
• Site Qualification Visits
• Submission and Approval from DCGI for trials in India
• EC submissions and approvals
• Site Initiation Visits
• Routine Monitoring Visits
• Investigational Product and Materials accountability
• Source document verification and tracking and review of completed CRF
• GCP, SOP and Protocol compliance at site
• Effective study conduct 

Roxaane Advantages :

• Combined experience of over 50 studies involving 50,000 subjects
• 300 + Principal Investigators
• Tie ups with specialty sites
• Protocol and site specific recruitment and retention strategies
• Proactive project management with contingency planning
• Dedicated study team till study close out
• Rigorous therapeutic area and compound based training
• Central and regional CRA's for maximum efficiency
  

We offer a personalized range of Pharmacovigilance services that are involved with offering & maintaining safety of our patients and giving other medical support at the site.

The team consists of :

• Project Leaders
• Drug Safety Associates
• Medical Reviewers

There are several Physicians and doctorates with experience in Pharmacovigilance practices for trials across a wide array of therapeutic indications. Their expertise includes the technical as well as the global trends and applicable regulatory guidelines

Roxaane's Services Include :

• Serious Adverse Event (SAE) Management
• Assessment of Causality and Expectedness of Adverse / Serious Adverse Events
• Preparation of Alert letters (Dear Doctor)
• Medical Monitoring
• Authoring of SAE narratives
• Authoring of Pharmacovigilance documents 

Roxaane Advantages :

• Physician team with varied experience
• Trained in global Pharmacovigilance practices
• Thorough understanding of Client and Regulatory requirements
• Firm timeline commitments with flexible adaptations
• Customised solutions complying with applicable regulations

We offer personalized range of medical writing services that we undertake on the behalf of our clients. Our medical writing is accomplished by our team of competent professionals including several Physicians and doctorates in pharmacology. These members with their years of experience in medical writing serve our clients in the best possible manner. The team consists of several Physicians and doctorates with varied medical writing skills. They possess trained and tested capabilities and excel in effective team playing .

Roxaane's Services Include :

• Protocol Writing
• Authoring of Periodic Safety Update Reports
• Medical Communications
• Manuscripts and Abstracts
• Issue Work Ups
• Clinical Study Report

Roxaane Advantages :

• Physician team with global experience
• Dedicated team approach for individual client
• Thorough understanding of Client and Regulatory requirements
• Firm timeline commitments with flexible adaptations Faster turnaround time 

In order to serve our clients in an efficient way we offer them with a well organized clinical data management services. Our clinical data management team comprises of :

• Project Leaders
• Database Administrators
• Clinical Programmers
• Medical Coders
• Data entry personnel

The team has a mix of engineers and life sciences professionals with several years of experience in clinical data management and have worked for Multinational CROs and KPOs. They have good experience on industrial standard CDMS like Oracle clinical, Data Fax, Inform, Rave, Clintrial. 

 Roxaane's Services Includes :

• Extraction of CRF work flow and parameters
• Case Report Form(CRF) Designing
• Database Built and Programming
• Double Data Entry and Adjudication
• Discrepancy Management
• Medical Coding
• Clinical Report Generation
• Quality Review
• Database lock and data set export 

Infrastructure :

• Oracle clinical with RDC
• SAS Pheedit
• WHODD
• MedDRA
• Crystal reports

Our Production servers are hosted at a Level III data centre with redundant IT infrastructure like power and internet connectivity, with regular scheduled backups and disaster recovery. 

Roxaane Advantage :

• Combined experience of several hundred studies
• Thorough understanding of Clinical, Technical and Regulatory aspects
• Firm timeline commitments with flexible adaptations
• Coding by qualified Medical Personnel with Physician supervision
• Customised report generation in real time
• Smart CRF design to reduce redundant data
• Broad experience with all industry standard CDMS
• Therapeutic Area experience includes: Oncology, Orthopedic, Metabolic Disorders, CNS, Dermatology and Cardiovascular disease
  

We provide reliable range of clinical quality assurance services to our clients considering the importance of quality assurance for clinical studies all over world. Offering clinical quality assurance services requires great criticality from our end. The CQA group includes professionals with a background in clinical monitoring, auditing and development and implementation of quality systems.

The Roxaane CQA group is the custodian of the Roxaane SOPs across all functions and is responsible for updating, maintaining and ensuring adherence within the company. In Roxaane, the CQA group also functions as the initial training facilitator wherein all new employees are trained in ICH-GCP and 21 CFR Part 11 by this group. They also ensure that Roxaane complies with all the applicable guidelines and regulations at all times.

We offer a qualitative and reliable range of Biostatistics services that are effectively provided by our team comprising several engineers and professionals certified and trained in SAS. These members are rigorously trained in various phases of Clinical trials to help the clients in the best possible way. Roxaane's Team comprises of several SAS programmers and professionals certified and trained in SAS. These programmers are industry trained, across therapeutic areas in various phases of clinical trials.

Roxaane's Services Include :

• Development of Global SAS macros
• Generation of Tables, Listings and Graphs
• Validation of SAS programs
•  Preparation of customised reports

Roxaane Advantages :

• Client focused approach
• Broad expertise across therapeutic areas
• SAS certified team members
• Faster turnaround time and greater flexibility