Dr Christophe Tournerie, CEO
Excellence in clinical drug development can be quantified by three factors: the ability to access relevant resources and expertise, increase the speed of drug development, and validate the efficacy of the products released to the market. One of the most critical parts of drug development is patient recruitment for clinical trials – which potentially makes or breaks the successful release of the drug. For example, during the COVID-19 pandemic, high numbers of vaccine trials overwhelmed the enrolment and start-up periods for pharma companies, resulting in logistical issues that impaired drug delivery.
At such critical junctures, pharmaceutical companies have continually sought the expertise of CROs such as ClinActis that offer specialized capabilities, regional know-how, and technical assistance to help advance clinical programs in a dynamically changing environment. ClinActis, an exclusively Asia Pacific focused CRO, has garnered extensive experience within the industry, working with international pharmaceutical and biotechnology companies developing drugs and aiming for local FDA and other registrations, and has a thorough understanding of the local context in each country. As a result, the company ensures a client’s clinical trial success through customer-centric services tailored to the region’s specificities and with cutting edge services and cost-effective solutions.
Reliable and Expedited Approach for Patient Recruitment
Patient recruitment is a critical aspect that minimizes the time required for drug development and is essential for clients, and ClinActis understands this very well.“We provide clients with the best expertise in the Asia Pacific region, without compromising with the international quality standards,” states Dr Christophe Tournerie, CEO of ClinActis. Pharmaceutical organizations have flocked to Asia to recruit patients for clinical trials, owing to the larger and diverse populations residing within the region. Thus, conducting clinical trials for specific ailments is an easier and more cost-effective avenue within Asia than the rest of the world. ClinActis taps into this ocean of potential, helping clients effectuate their clinical development processes. Because clinical studies can only be completed on time if patients are recruited quickly and at a competitive cost. The company accomplishes this by operating in the Asia Pacific region, which has a large treatment naïve population with diseases from both developed and developing countries, which offers solid prospects for significant and rapid patient recruitment. The inclusion of investigator sites in Asia also helps in reducing the overall drug development timelines; a higher number of patients in fewer sites enables faster patient recruitment.
Based on the research phase and therapeutic area of a client’s trial, ClinActis assists them in determining the optimal approach for the development of their product. The Company provides clients with a thorough comprehension of establishing complex procedures and evaluating variations of global drug development standards applied to each country’s regulatory and research specificities.
ClinActis establishes relationships based on trust, transparency, and strong ethics by proactively working with clients and participating in their ventures. Many clients seek out ClinActis to obtain assistance in safely accelerating clinical drug development and achieving exemplary results.
Interestingly, the company customizes its Functional Service Provider (FSP) and resourcing services to create a model tailored to a client’s development needs. For a single project or position or as part of a broader FSP partnership, ClinActis provides qualified and experienced personnel, as required by a client across numerous functions.
ClinActis’ clinical teams ensure clear written communications for sites, investigators, and regulatory agencies throughout the product development and commercialization process, from protocol creation to clinical study reports and regulatory paperwork. Additionally, ClinActis uses SOPs for clinical research compliance with ICH and GCP requirements to assure the safety and integrity of a client’s data.
A Beacon of Uncompromised Clinical Project Management
Clinical project management is one of the flagship services provided by the company to its clients, which ensures proper planning for their entire trial. ClinActis’ team, which has worked in a variety of pharma and biotech businesses as well as CROs outside of Asia Pacific, has extensive expertise in clinical research management and is leveraging that experience to assure effective trial planning for customers. As an expert in clinical project management, the company uses various tools like project plans, communication plans, and monitoring plans that ascertain the successful completion of a study. More importantly, ClinActis anticipates risks and prepares contingency plans that can be implemented quickly, preventing any disturbance to a client’s ongoing trial. It actively engages with its clients from the start of research and provides local monitoring services based on its vast understanding of a region. The company assigns locally-based CRAs in each country, knowledgeable of their region’s regulatory requirements, and ideally, have experience monitoring global international clinical trials in the context of their local environment.
We provide clients with the best expertise in the Asia Pacific region, without compromising with the international quality standards
The Project Managers serve as a primary resource and point of communication for the client and project team; they provide leadership and direction, including time specifications, quality, and cost of deliverables.
To accelerate the study, the assigned CRAs oversee the company’s global capabilities, systems, and processes; as a result, it assures efficiency and accuracy throughout the project.
The CRAs create a management framework to optimize the skills of functional leads and drive focus on the quality and efficiency of individual tasks.
Assistance from the Beginning to the End of a Study
As a reliable partner, ClinActis commits to assist its clients and provides them with a full service that starts from preparing a protocol for clinical trial till the final study report’s preparation, which proves beneficial for small pharma organizations. The company evaluates critical components of a protocol and understands how they could influence the trial’s requirements, thereby making it feasible for the company to give an appropriate strategy for each protocol.
We can assist our international clients in conducting research in Asia with the best strategies possible, taking into account their needs as well as the country’s socio-economic situation
As evidenced by ClinActis’ collaborations with pharmaceutical stakeholders, a thorough understanding of clinical trials, alongside expertise in trial execution, ensures smooth client project completion on time and within budget. And, ClinActis provides just that, assisting stakeholders throughout the clinical value chain and empowering clients to reduce time to market and operational overheads of their research and developmental ventures. Thanks to its lean organization, ClinActis’ top management is able to directly support the sponsors, bringing an unparalleled level of seniority and expertise in Asia Pacific to its clients, in order to achieve their goals most effectively.
More importantly, the company stipulates guidelines for a client to prepare a dossier to support the regulatory approval of the clinical trials. ClinActis, with its expert inductees, manages to obtain all approvals necessary for a pharma customer in terms of the ethical committee and regulatory body. Additionally, for international clients with no prior business experience in the Asia Pacific region, the organization assists in developing a plan to select a country and the number of investigator sites required to complete clinical trials. “We can assist our international clients in conducting research in Asia with the best strategies possible, taking into account their needs as well as the country’s socio economic situation,” states Christophe. Understanding and knowing how to execute trials ensures a smooth process and assures that a project is completed timely and within financial constraints.
In addition to such comprehensive capabilities, ClinActis continues to improve its customizable clinical trial operations by expanding footprint across several countries. It is safe to say that with such astounding customer-centric and efficacious solutions for a global market, ClinActis will be a dominant and one of the most sought-after CROs in the Asia Pacific region.