The ultimate aim of a drug development program is to obtain regulatory approval with an optimal label that will ensures commercial success.
Scientific advice helps to ensure that developers perform the appropriate tests and studies, so that no major objections regarding the design to the trials are likely to be raised during evaluation of clinical trials or marketing-authorization applications.
Highly qualified expertise professionals are required to develop a successful Clinical Development Plan, the blueprint of the entire clinical research strategy of a drug which defines the critical path for the clinical program including development assessment and decision points and the project resource estimates
Our experts network advises on your investigational product to enhance patient’s lives and become an effective component of healthcare system.
Patient advocacy groups play an important role in clinical trial to build relationships that give the powerful patient insights. Our team can coordinate the patient input on study design and trial feedback for protocol improvement.
Benefits from patient association collaboration includes access to non-identified patients for recruitment and acquire insights to better understand disease states, patient needs and trip participation problems.
Patient engagement from the start allows further advance on your clinical trial outcomes.
Regulatory Research Strategy
The fastest route for clinical trials approval starts well before clinical trials are initiated, to understand both the regulatory landscape (i.e., guidelines, important stakeholders, emerging policies) and relevant precedents.
Regulatory guidance in these areas can help to build a crucial framework for the overall development plan and aid in determining the fastest and/or greatest value path.
With a comprehensive regulatory strategy in hand, sponsors can fully understand the expectations, carefully evaluate potential hurdles and create a plan to proactively address them early.
Centralized Monitoring Clinical Trials
On multicenter clinical research, centralized monitoring is the most efficient way to ensure patient safety, trial integrity and data quality, as it permits the study team to proactively detect anomalous data trends.
Centralized Monitoring improves the quality of the regulatory submissions with a direct impact on the time to marketing approval.
With the emergence of new technologies, clinical research is more data-driven that ever. Therefore, today, regulators encourage the use of centralized monitoring in conjunction with on-site monitoring to oversee clinical trials.
The key steps involved in centralized monitoring implementation are as follows:
- Identification & defining key risks and their thresholds.
- Designing a comprehensive monitoring plan & relevant documentation.
- Continuous monitoring of risks or issues using the right technology.
- Corrective action planning to manage and/or mitigate identifies risk/issue(s).
The newer approach of a central monitor, it is important to ensure the right expertise and trained resources in place to drive the process. Experience on monitoring, good knowledge of data management, with good analytical skills, apply critical thinking to identify trends and outliers especially those risks related to data quality or patient safety.
Quality Risk Management
Within the implementation of ICH GCP E6 R2 and optimal balance of time, risk and costs are required to maximize the final outcomes.
The importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality management systems (QMS).
Our team provides GAP analysis of QMS, revises and implements QMS including SOPS, supports on quality assurance such as evaluation of issues, reviews of suggestions for corrective and preventive actions, as well as quality control activities with auditing services of investigation sites, critical suppliers, essential documents, pharmacovigilance and co-monitoring.
Our life sciences team on clinical development and medical affairs can provide solutions to our customers with specific needs being covered by Nurses, Physicians, Medical Monitors, Medical Advisors, Clinical Monitoring, Data reviewers, on line services to a wide variety target audience.
The advantages of e-Services model are the scalability, flexibility, sustainability while ensuring the expertise required.