Clinical Trial Management
A Stronger Start for the Clinical Development Journey
A journey from a molecule to the market requires a strong beginning to have the best chance of regulatory approval and market access.
In today’s ever-advancing medical field, clinical trials serve an essential purpose to determine if a medical treatment, device, or medication is safe and effective. Clinical Trial Management (CTM) supports the journey of the drug from clinical to market through the clinical phases for either an Investigational New Drug Application (IND) or a Biologics Licensing Application (BLA) via., phase I (Early Development), phase II (Exploratory Studies), phase III (Confirmatory Studies) and late phase IV clinical trials which also includes real-world studies. The Clinical Trial Management team help set you up for success through our best-in-class Phases I and II clinical research services. As a part of first in human studies (phase I) a Quantitative Clinical Development (QCD) combines clinical pharmacology modeling and simulation with clinical PK/PD for a more strategic approach to clinical development, reducing the time and cost of bringing drugs to the market. By leveraging mathematical models for quantitative analysis of the relationship between drugs, disease, and patients, modeling and simulation can predict a drug’s benefits and adverse effects in a patient population prior to conducting a clinical trial or clinical research. In addition, the use of quantitative clinical studies in pharmacology throughout the life cycle of a drug candidate supports high-quality regulatory packages to help secure regulatory approval. Clinical Trial Management provides critical support to ensure success and efficient delivery at every phase of global trials. An experienced and dedicated Clinical Trial Manager leads all aspects of the study–working closely with the global cross-functional project team, and other vendors to seamlessly execute the trial.
A dedicated team of experts provides with the required scientific, therapeutic, and regulatory expertise to design and implement Proof of Concept Studies (phase II) for new drug entities across a broad range of therapeutic indications. This team offers customized solutions including the use of biomarkers and adaptive trial designs.
With the next steps of phase III, the attrition rate in the pharmaceutical industry remains high with a failure rate of 40 to 50%. To address this issue, there is now a larger emphasis on quantitative predictions and translational science from the early exploratory stage through pre-clinical development and into the clinical arena. This has led to greater use of pharmacokinetic (PK) and pharmacodynamics (PD) data analysis, to better understand a drug’s mechanism of action, efficacious dose size, and therapeutic index. This information allows pharmaceutical companies to make better decisions earlier and select drug candidates with the greatest chances of success, thus increasing the success rate during late-stage clinical trials.
With late phase studies, the services provide a pharmaceutical company with the management of Life Cycle Management (LCM) for the product. Be it either the post-approval fulfilments or the observational studies/ non-interventional studies, the clinical trial management helps in fulfilling the obligations of the late phase studies with the full potential.
To ensure the smooth operation and effectiveness of clinical trials (across the phases), qualified professionals are essential. A Clinical Trial Manager directs the process of clinical trials by using effective organizational strategies and reviewing the results using rigorous clinical procedures. In all activities, a clinical trial manager must respect confidentiality and privacy and abide by safety standards.
A Role Description of a Clinical Trial Manager:
- Is to prepare protocols and case Report forms (CRFs) and completing monitoring and data management options.
- Is responsible for the development of recruitment methods to increase patient randomization into the trial, approval for trials from an ethics committee, delivery of materials for clinical trials, and coordinating the trial to make sure it runs smoothly.
- Trains, directs, and manages other professionals, such as clinical trial investigators, clinical trial nurses, and other clinical trial associates.
- Make sure all individuals are up to date on all aspects of a clinical trial.
- Spends a great deal of time communicating with other professionals via phone, email, and face-to-face meetings to make sure the whole clinical trial team consistently knows of any relevant information and issues.
Besides the above drug applications, for a generic pharmaceutical company developing generic pharmaceuticals have anything but generic needs, with an NDA or ANDA applications, CTM has developed a deep understanding of the unique requirements of generics, having decades of experience in partnering with diverse generic pharmaceutical product development companies of all sizes. We support generic pharma companies by performing bioequivalence (BE) studies in healthy volunteers with confidence, on time within the allocated budget. With increasing public demand for generic pharmaceuticals, there is great pressure on development timelines for generic companies. There are considerable benefits to being first to market, and the team helps the generic companies complete their clinical development sooner and with confidence.
- Competitive Intelligence: Protocol feasibility, Competitive landscape, Pipeline assessment, Enrolment, and site performance analysis
- Clinical Trial Start-up Services: Recruitment strategies and materials development, Site feasibility and qualification, Essential document collection and verification, Ethics committee package preparation and submission.
- Remote Quality Oversight to Trial Conduct: Clinical trial management (pharmacy and drug-related aspects), Site visit report review
- Clinical Trial Insurance Management: Insurance certificate, renewals, policies as per country regulations
- Clinical Trial Contracting and Payments: Negotiation and clinical trial agreement/amendment execution, Investigator payment processing
- Dedicated clinical operations teams that are experienced in all aspects of early clinical activity and site management (safety, labs, monitoring, technical training, cohort review, and recruitment screening).
- Relevant technologies include Interactive Voice and Web Response Systems (IVRS/IWRS) to randomize patients and track drug inventory and electronic data capture to provide rapid access to study data.
- Operational flexibility that supports uniquely customized solutions such as multi-stage dose escalation protocols.
- Integrated planning and management to take programs from IND through Proof-of-Concept under a single contract
- Unique SOPs across the functions.
- Therapeutically aligned teams with expertise in different therapeutic areas.
- Dedicated teams of Clinical Data Management, Biostatistics, Statistical Programming, Clinical Research Support, Medical Writing, Regulatory Intelligence, Safety Management, and Medical Operations.
Our approach matches the strategy used by the pharmaceutical company to reduce the cost of outsourcing. Clinical trials are essential to the healthcare industry in developing new treatment methods and medications for an array of medical conditions.