Translation of an invention from lab to bed requires successful crossing of predefined set regulatory milestones. Each milestone is linked to the underlying scientific invention. This translation over a decade require cross-disciplinary expertise to finetune the invention across all the stages. In general, translational medicine leverages pre-clinical data, pharmacokinetic and pharmacodynamic analysis, biomarkers and genetics to predict and optimize the outcomes. Rhenix brings right people for your translational activities to get right treatments to the patients.
On the outset, trial feasibility starts with broad considerations of regulatory framework and patient enrollment within the geography. Strategic guidance involves leveraging multiple sources of data that can provide insights within the context of protocol parameters. Rhenix places an emphasis in generating insights and guidance to the sponsor on current treatment options, standard of care and cultural nuances within the geographical area. Supported by strong team of local scientists, Rhenix places strong emphasis on regulatory pathway for approval within the country. Our process involves informed decision making regarding the site selection and patient population and the tradeoffs.
Rhenix believes feasibility strategy has to unlock the commercial pathway with available resources and within the budgets. This requires a thorough understanding of local business ecosystem, doctor-patient relationships and its dynamics, and the overarching regulatory framework. Rhenix performs competitive landscape and develop a strategy that is unique for the specific country.
We provide strategic guidance to support your trial. Our experts from protocol development, study design, regulatory framework working in tandem with business specialists create a robust analysis that will become the core tenant of your study. All this will be done under the guidance of therapeutically focused global experts within the disease domain.
Can a checklist actually accomplish anything without due diligence? Process redundancy and repetitive documentation creating multiple exclusive silos are the major challenges for any trial. A checklist doesn't solve these problems. Each site comes with its own set of challenges: supporting personnel, patient demographics and dynamics, systemic or institutional processes and their silos etc. The apriori knowledge of the site and our proprietary dynamic knowledge of the patient demographics within the geography is the premise of our study startup. Our site knowledge involves a rigorous estimation of site related silos, institutional guidelines, support personnel and the costs. Our proprietary models consider socio-economics, doctor-patients relationships, disease awareness and healthcare expenditures thus providing a exceptional granularity into patient enrollment. A more efficient client-centric and patient-centric approach that results in a compelling value for the sponsor, thus making it a sponsor-centric process design.
Documentation is the major operational component of any trial. We collaborate with the sponsors in developing end-to-end documentation: Protocols, IRB documents, Institutional documents, Trial brochure for all the stakeholders and on-going reports after the start of the trial. Our dedicated staff working alongside of the sponsors and the sites streamline the documentation flow while maintaining the local regulatory, institutional and legal guidelines.
The writing starts with the protocol development. This is the "constitution" of the trial with all the details: scientific and operational that governs the trial at a specific site. It describes how a clinical trial will be conducted: the objectives, design, methodology, statistical considerations and organization of a clinical trial, and ensures the safety of the trial subjects and integrity of the data collected. A well designed, concisely written protocol communicates all the elements that are required to communicate with investigators, study staff, IRB and other committees, regulatory authorities and patients. It is a multi-disciplinary effort combining members from scientific, clinical, operational, finance teams, medical writers taking the lead. Our medical writers leverage the sponsor-provided background information and boundaries to develop comprehensive protocols in compliance with ICH and regulatory authority requirements. Compliance (ICH, GCP, E6) is critical in developing the protocols and must adhere to the principles of Good Clinical Practice before being submitted to the Ethics Committee/IRB. Most importantly the protocol should adhere to region-specific requirements.
An investigator's brochure (IB) is a compilation of clinical and non-clinical information that summarizes the trial. The brochure is distinctly different from the protocol. The purpose is to provide data relevant to the trial gathered either during preclinical or other trials to the investigator that is necessary for the management of study through out the trial. It consists of information regarding the dose, frequency. methods of administration, safety monitoring procedure and real world evidence collection mechanisms. On the other hand, a distinctly different brochure is required for the patients with a focus on possible interventional benefits, safety issues and appropriate regulatory contact information. Rhenix is focused on delivering writing to manage an end-to-end trial.
Data is the most critical part of the trial that impacts the legal, scientific and regulatory aspects. Essentially it is the one piece that constantly keep generating, moves and needs tracking appropriately under proper guidelines (for ex. (CFR), 21 CFR Part 11). The protocol defines the data collection, analysis methods but proper articulation of processes, data collection methods and process implementation under HIPAA guidelines is critical. With appropriate checkpoint and continuous evaluation, Rhenix is focused on bringing the quality data into trial. Our staff working alongside the teams from the sponsor and site are always focused on patient engagement and deliverables within the budgets.
On the other hand, patient centricity is another critical component. Patient engagement and experience within the context of clinical trials is broadly defined in three phases: pre-enrollment, enrollment and post-enrollment. Each phase requires distinctly different documentation and people under the supervision of the investigator. Creating processes and checkpoints without redundancies and bottlenecks is the key. At the same time, having a continuous access to their data, sometimes establishing offline access through direct communication is critical. We at Rhenix bring this knowledge beforehand and minimize interruptions while improving the data quality.