Our Services
Clinical Operations & Project Management
MedClinica provides expert clinical trial services to the pharmaceutical and biotechnology industry. Our staff is skilled in clinical trial management, execution of study feasibility assessments, expedited study start-up, patient recruitment and clinical monitoring.
Our dedicated team has vast experience in coordinating phase I to IV trials globally. We can perform all Phases of Clinical trials – from feasibility to Study Close Out – with utmost quality standards.
Clinical Operation Services :-
Clinical Data Management
MedClinica provides customers with centralized, coordinated Data Management Services Globally. We develop flexible and customized Data Management Plans in compliance with all applicable regulations; we specialize in offering customized reports to customers at timely and periodical intervals to get the complete feel of the conduct of the study.
MedClinica Team comprises a pool of highly talented Data Managers with vast experience who are well trained in ICH-GCP and GCDMP with work exposure across the therapeutic areas; having expertise in handling clinical trial data from Phase-I to Phase-IV studies for Submission to Regulatory bodies to name few USFDA, EMA, TGA & DCGI Local and International.
MedClinica team is highly experienced eCRF based studies. MedClinica Data Management team is flexible in adopting to the Sponsor specific tools like MEDIDATA Rave, InForm, and other EDC Solutions
MedClinica Clinical Data Management Services:
Biostatistics & SAS Programming Services
MedClinica understands the importance of Biostatistics & SAS in clinical research and therefore we strive to provide quality services and solutions.
All our SOPs, procedures, processes and Biostatistics services are based on ICH – GCP guidelines and SDTM – CDISC standards. Our team is knowledgeable and well-experienced Biostatistician and Statistical Programmers who are dedicated to delivering SDTM – CDISC standards with a wide range of therapeutic areas and to all phases of clinical trials by emphasizing process optimization and accelerating timelines while ensuring quality.
Medical & Scientific Writing
MedClinica understands the importance of Biostatistics & SAS in clinical research and therefore we strive to provide quality services and solutions.
All our SOPs, procedures, processes and Biostatistics services are based on ICH – GCP guidelines and SDTM – CDISC standards. Our team is knowledgeable and well-experienced Biostatistician and Statistical Programmers who are dedicated to delivering SDTM – CDISC standards with a wide range of therapeutic areas and to all phases of clinical trials by emphasizing process optimization and accelerating timelines while ensuring quality.
MedClinica Medical Writing Services:-
Regulatory Services
A well-designed and implemented regulatory strategy is a critical step in getting approval for the Marketing Authorization of a product to market quickly and in a cost-effective manner. MedClinica team has developed a deep understanding of the intricacies of the regulatory process that only comes with years of working with the Regulatory Authorities and numerous pharmaceutical, device, and biotech companies, and various contract research organizations and other vendors.
MedClinica Regulatory Services:-
Quality & Audit Services
MedClinica Independent Quality Assurance function directly reports to top management for all Clinical trial aspects. We do provide Quality Assurance & GxP Audit services to Pharmaceutical, Biotechnology, and API manufacturers and medical devices.
Safety & Pharmacovigilance Services:
Medical Device Services:
Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, Regulatory Submissions & Liaisoning.
