Service Solutions

Regulatory Affairs

From bench-to-bedside is a long, complicated, resource and cost exhaustive journey which every pharmaceutical product has to go through before seeing the light of the market. The complex, tough and diverse regulatory paradigm across the world adds to these challenges.

CliniRx understands these regulatory challenges and provide tailored, product specific regulatory solutions to meet Sponsor expectations with respect to cost, time and quality. CliniRx has highly experienced, and trained regulatory professionals who can collaborate with Sponsor in strategizing a regulatory path for the pharmaceutical product (whether it be drug, biological, medical device or cosmetics). CliniRx’s regulatory knowledge and extensive understanding of regulatory machinery will provide Sponsor a clear perspective of regulations across key geographies and will help to clear any apprehensions.

Regulatory Affairs services at CliniRx include:

• eCTD Regulatory Dossier Preparation, Publishing and Submission
• Global Regulatory and Scientific Advice strategies preparation, meeting and execution at all stages of development
• Program review (including pre-clinical, pharmacology, CMC and clinical elements)
• Regulatory management through full product life cycle
• Regulatory strategy and agency communication to obtain first-cycle approvals

Consulting: Planning and strategy are key to success and CliniRx regulatory personnel are experienced in providing customer/product specific regulatory solutions which will meet Sponsor expectations in terms of cost, time and quality.

Local Applicant Support: CliniRx provides local regulatory support in key geographies. To conduct a clinical trial, Sponsors have to collaborate with a legal, registered entity in that geography. This is not just an administrative support and entails responsibilities and accountabilities. We as a team are fully prepared to take these responsibilities and accountabilities.

Filling Regulatory Applications: Quality output is only possible with a quality input. CliniRx understands and applies this concept in every aspect of its process driven services.

CliniRx has trained and experienced team who supports in compiling the technical dossier, conduct quality check and submits to the regulatory agency. Liasioning with regulatory agency post submission to expedite review and approval process is key. A combination team including medical and regulatory experts supports Regulatory Meetings.

County specific Registration: CliniRx supports registration to the country specific national website, such as clinicatrials.gov,

Post-Approval Maintenance: It involves various submissions like protocol amendments (substantial & non-substantial), IB amendments, Change of site/PI, DSUR & PSUR submission, registration and license renewal etc. CliniRx being the partner organization will support Sponsor with end to end solution.

Safety Reporting: Safety Reporting (Expedited, Periodic reporting, ) is undertaken in key geographies in the world.

• Eudravigilance
• MHRA
• FDA
• TGA

Quality Assurance

CliniRx is a quality driven organization with well documented quality management system (QMS). We believe that quality starts within the organization by establishing a quality culture in which employees “live” quality in all their actions. Our quality assurance experts are highly trained, experienced and competent. Our approach to quality is one that demonstrates our commitment towards meeting or exceeding your expectations. Once awarded a project we will make sure that quality is built into the project from the day one.

Our flexible organizational structure where quality assurance can operate independently, peoples approach to quality, effective communication, knowhow of global standards, and proactive solutions, make us unique and helps to be leader in the clinical research quality assurance service domain.

Our Quality Assurance Services Include:

• Project Specific Quality Compliance Assessments. Involves review of essential documents, regulatory green signal process, vendor due diligence, TMF assessments, clinical trial site assessments, process level assessments etc.
• Good Clinical Practice (GCP)/Compliance Audits. We offer following types of audits- investigator site, vendor, trial master file, database, document, pharmacovigilance, labs, institutional review board or ethics committee and Good Manufacturing Process (GMP). We also undertake effectiveness audits of QMS, training programs and Corrective Action & Preventive Actions (CAPA).
• SOP/WI, forms and templates development for various stakeholders like Site Management Organization (SMO), Contract Research Organization (CRO), Sponsor, Clinical Trial Sites and Ethics Committees.
• Preparation of Sponsor/CRO/SMO, clinical trial sites and other vendors for regulatory inspection or independent audits.
• Quality Assurance Trainings for all stakeholders (e.g. vendors, clinical trial sites, ethics committees, sponsor personnel etc.)

Our Excellence Factors:

Customer Focused

Employee Empowerment

Well Documented QMS

Internal and External Assessments, and Process Control

Employee Trainings

Effective CAPA

Compliance with Global Standards

Effective Communication

Leadership Drives the Quality Culture

Continuous Improvement

Clinical Monitoring

Team meticulously selects CRAs based on their experience in appropriate therapeutic area.

A strong training program then sets base for the interface between the project team and the Investigator, where CRAs demonstrate high levels of site management skills to ensure that issues at sites are addressed quickly and completely, allowing sites to work efficiently and maximize data quality.

Strategically located regional CRAs ensure local knowledge, language, and cultural understanding, as well as to reduce travel costs and increase efficiency.

Clinical Operations team takes training on priority, thus, specific and personalized training program runs throughout the year. This results quality CRAs assigned to a study.

Data Management & Biostatistics

CliniRx has an extensive experience in collecting, storing; analyzing, interpreting and presenting clinical data. Our in-house clinical data management experts are committed to upholding a standardized, process-driven approach by using the state-of-the-art tools such as Medidata, INFORM, etc. Our experienced biostatisticians are able to demonstrate efficacy of a drug or a medical device and present results in the clearest way possible. CliniRx complies with ICH/GCP, CFR PART 11, GDPR, and other data protection guidelines.

Key services are: