Our success stories to tell
FDCs must be based on convincing therapeutic rationalization and be carefully justified and clinically relevant. We helped our sponsor to prove the therapeutic rationale for various FDCs by conducting PIV clinical trials in India for gastroenterology, Gynaecology and Respiratory therapeutic areas.
PMS/PSUR being conditioned for Market Authorization and licensing in India. The PSURs are to be submitted every six months for the first two years of the approval and for subsequent two years annually. We have conducted/conducting PMS studies for our sponsor as per “New Drugs and Clinical Trials Rule, 2019”. This has helped the sponsor to meet the prerequisites as per the regulations.
To claim marketed drugs with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug (SNDs) approval required from CDSCO. Here, CliniExperts supported our client to conduct PIII, PIV and PMS studies as per CDSCO guidelines.
Clinical trials for phytopharmaceutical drugs to be conducted as per applicable Rules and guidelines for new drugs. CliniExperts Research conducted three PIII clinical trials for three therapeutic conditions in India.
CliniExperts has helped in conducting PII, PIII and PIV clinical trial in diversified therapeutic categories like Polycystic Ovary Syndrome (PCOS), Recurrent ascites with liver cirrhosis, Premenstrual Syndrome, Primary Dysmenorrhea and Alopecia Areata in children and adolescents.
Most of the patients in intensive care unit (ICU) with impaired oral food consumption, present nutritional challenges which needs to be compensated using enteral tube feeding (ETF). We have successfully conducted safety and tolerance of nutritional supplements via tube feeding in hospitalized patients
Functional food supplements has grown exponentially in India and to prove their claims, feasibility and safety evaluation studies are required. CliniExperts Research has conducted various studies to prove their claims like Glycaemic Index evaluation of product on Diabetic and Pre-diabetic population and many more.
Details Depicting Stats
CliniExperts can assist their clients in smoothly managing the trials.
Service categories which we effectively handle:
Clinical Project Management
competent management of time, resources and budget
A poorly managed clinical trial can lead to delays and increased costs; efficient and well-structured project management is the basis for a successful clinical trial.
Adept with excellent leadership, negotiation and communication skills, our project management Team will ensure all relevant data to support your study goals are managed with utmost integrity. Your dedicated project Manager will ensure competent management of time,resources and budget throughout the project.
Our project managers have the experience and expertise to offer operational solutions to the toughest project challenges and ensure your project is delivered on time with quality. Their involvement begins with the proposal and continues through the evaluation and selection of qualified sites, right up to the project closure.
Critical to a successful clinical trial is the efficient management and monitoring of clinical sites. We have an exceptional track record in clinical trial monitoring that ensures scientific excellence and data integrity across all sites.
We engage highly competent clinical research associates to perform all aspects of site management and monitoring. Our Clinical Research Associates exercise ultimate efficiency in managing investigator sites and focus on ensuring adherence to data quality, subject safety, and early issue resolution throughout the trial. Comprehensive monitoring plans are crafted to address trial complexity and sponsor requirements. As part of our site management services, we also help to upskill site staff to meet industry compliance standards and ensure that the site and the staff are adequately prepared for audits and inspections.
Clinical Site Management
managing sites, focus on ensuring adherence to data quality & subject safety
Vendor selection for conduct & budget trial
For services that we don’t offer, we can identify and enable successful third party vendor partnerships. We have the right people with functional capabilities and skills to oversee the vendor relationships effectively.
We will fully explore the vendor’s process and evaluate the vendors using specific criteria such as track record, technical competence, and flexibility. We strive to take appropriate measures for controlling cost, reducing potential risks, ensuring excellent service deliverability, and deriving value from vendors in the long-run.
The expertise needed for clinical trial success should never be overlooked; we ensure clinical trial compliance, conduct, budget, and ultimate success with the selected vendor.
Effective data management principles are critical for any scientific domain. In clinical research, the process of collecting and managing research data is done in accordance with stringent regulatory standards to obtain quality information that is complete and error-free.
CliniExperts offers a wide range of Clinical Data Management services. We provide services from the design of the Case Report Form to the delivery of complete and accurate data in a customized output format. We also offer comprehensive training to use Electronic Data Capture (EDC) systems effectively. We combine experience with technology and ensure actionable outcomes and highest quality and integrity in terms of the data we deliver.
Clinical Data Management
Design of the Case Report Form to the delivery of complete and accurate data in a customized output format
Medical Writing and Medical Monitoring
high-quality clinical study documents compliant with ICH guidelines
Our team of experienced medical writers possesses comprehensive knowledge and experience to cover the different demands of medical writing in clinical research. We provide high-quality clinical study documents compliant with ICH guidelines and applicable regulatory requirements. Our medical writers have a thorough understanding of the various guidelines and regulatory requirements, which leads to the generation of correct and comprehensible regulatory documents.
Our Medical Monitoring Services encompass medical surveillance of your trials by experienced clinicians to ensure patient safety. The clinicians assess the eligibility of subjects for corresponding trials and supervise processes to maintain consistency of collected data. Furthermore, our medical experts provide ongoing training to site staff on matters pertaining to treatment and safety.
Apart from the above services, we also provide Subject Expert Committee (SEC) meeting support. We assist you in understanding the SEC review procedure and the recommendations from regulatory authorities. We review application for:
We review application for:
We also help in preparing scientific presentations for SEC meeting; these presentations will be reviewed by our team of medical doctors and regulatory experts who have attended several such meetings and are thus, well-versed with the requirements of SEC meetings. We will assist you during each step of the SEC meetings – from presenting scientific / technical presentations, delivering it and answering the queries raised by experts. We can also support you during post-approval queries or in implementing changes required after document submission.
SEC Meeting Support
Assistance during each step of the SEC meetings – from presenting scientific / technical presentations, delivering it and answering the queries raised by experts