Services We Provide

By: Crofessionals  09-12-2011
Keywords: Project Management, quality assurance

Whether you're looking for study monitoring only or full-scale clinical trial management, CROfessionals is always willing to meet your individual research needs, with a comprehensive service menu that includes:

  • Protocal Design
  • Feasibility Studies
  • Site Selection and Management
  • Clinical Trial Monitoring
  • Full Clinical Project Management

Our clinical team combines specialized knowledge with operational know-how to establish a clinical research setting where patient well-being is paramount and dependable results are a given. Using a team approach, we provide centralized project management, continuous training and professional development, and, above all, absolute accountability every step of the way.

The end result is a rapid-response service oriented group of clinical researchers that is reliable, flexible, and cost-effective.

Regulatory Strategy

With pharmaceutical regulatory oversight more stringent than ever; regulatory expertise is critical to success. That's why at CROfessionals, we are especially proud of our recently expanded regulatory group. Under the leadership of Company President & Clinical Director, Sue Bhadare, we provide global consulting services and strategic development for all stages of drug development.

From sound advice to practical solutions, our team provides you with the expertise you need to design protocols, develop and implement regulatory strategies, prepare and submit regulatory applications, and facilitate communication with the Agency.

We will help you to understand what is needed to initiate clinical trials. We can work with clients on CMC and product development. We can also prepare clients for the expectations from the nonclinical requirements too.

It is key that companies understand what the Regulatory Authorities seek for successful initiation of clinical trials in humans.

We work with clients to go to the FDA with a well prepared pre-IND meeting package, so the clients come away knowing what is expected moving forward, allowing them to secure funding and plan for product registration.

Regulatory Submissions

Well-versed in US, Canadian, and European regulatory submission procedures, CROfessionals offers regulatory guidance, hands on support, and preparation of documents covering all aspects of drug development through marketing authorization. These include:

  • Regulatory lifecycle management
  • IND/IDE/CTA submissions and maintenance
  • Martketing authorization applications (NDA/BLA/510(k)/PMA)
  • Agency meeting and dossier preparations
  • Orphan drug applications
  • Agency Liason
  • US Agent
  • Clinical Study Reports

CROfessionals carefully reviews submissions to ensure compliance with appropriate regulatory guidelines.

CROfessionals is also available to help you create scientific presentations, grant applications, and research peer reviewed journal publications.

Quality Compliance and Audits

At CROfessionals, quality assurance that is both consistent and meticulous, forms the foundation of our business process. From the very beginning, our quality assurance team is on hand to ensure our CROfessionals Standard Operating Procedures are followed and written in accordance with CFR/EU Directives and ICH guidelines. We develop a quality assurance plan for each study, which details audit scope, content, and timelines.

Our QA auditors regularly review site data, regulatory documents, and other aspects of your study, providing you with ongoing audit reports, and recommendations for corrective and preventive actions, as needed. They also ensure that trial protocols are both understood and closely followed. Moreover, we audit ourselves carefully and continuously across all functions and throughout the life cycle of each study we conduct.

Our QA group is able to conduct independent audits for clients as a separate service.

New directives and safety regulations are constantly evolving for the protection of patients and public health, and in response to this, in 2010 CROfessionals launched its dedicated Pharmacovigilance Department.

At CROfessionals, we aim to provide accurate and comprehensive clinical and post-marketing safety surveillance in compliance with global pharmacovigilance requirements to ensure product safety. Our Pharmacovigilance team has extensive experience in both clinical and post-marketing environments and has developed safety monitoring processes that allow us to offer customized phase appropriate and cost effective solution for your pharmacovigilance needs to ensure compliance with increasingly stringent worldwide regulations.

We have a dedicated team of safety professionals with expertise across the following areas:

  • 24 x 7 Safety Report Receipt & Triage
    o Report receipt 24X7 on safety phone/efax/e-mail
    o Report triage & routing to appropriate stakeholder
  • Processing of SAE & ADR reports from Clinical Trials or Post-Marketing
    o Facilitate data entry into validated electronic database including historic safety data
    o Quality control
    o Safety review
    o Safety case narrative writing
    o MedDRA coding
    o Report Tracking
    o Report Preparation: Electronic (E2B), Hard copy (CIOMS, MedWatch 3500A drug, etc.)
  • Expedited safety reporting
    o Single cases to Competent Authorities, EMEA, FDA, Ethics Committees, Institutional Review Boards & Investigators
    o Post-Marketing safety reporting to Competent Authorities, EMEA and FDA
  • Periodic Adverse Experience Reports (PAERs)
    o PAER generation in compliance FDA postmarketing requirements
  • Product Quality Complaints (PQC) Management
    o Call receipt 24X7
    o Management of complete cycle from receipt of complaints to response to complaints
    o Complaint processing into database
    o Complaint distribution to client Quality Assurance locations and follow up for analysis report
  • Training of Pharmacovigilance and non-Pharmacovigilance staff
    o Project-specific pharmacovigilance trainings for clinical departments
    o Training on pharmacovigilance for clients and non-company employees
  • Writing and maintenance of client specific SOPs and Safety Management Plans SOP development
    o Recommendations for pharmacovigilance department designing and development
    o Recommendations for improvements in the existing pharmacovigilance system

Keywords: Project Management, quality assurance