Clinical Project Management

Clinical Project Management (CPM) involves planning and managing all aspects of a clinical trial. The CPM’s goal is to assess the safety and efficacy of drugs based on a range of legal claims and marketing. Nowadays, with increasing global regulations, the need for clinical studies has become more important and more essential for these CPM studies to be effective. In PPV ( as leading CRO in Iran ) in general, the CPM consists of a road map emphasizing four vertices below.

Overview: Establishment of project teams

CPM team involves planning and managing all aspects of a clinical trial. The goal of clinical trials is to evaluate the safety and effectiveness of pharmaceuticals, medical devices, or in-vitro diagnostic devices to support regulatory submissions or marketing claims. To successfully conduct a clinical trial, CPMs in PPV as leading CRO in Iran manage a team of CRAs and Clinical Specialists, and act as a liaison between the study sponsor and the clinical trial site. As a CPM, it is imperative to understand project management methodologies, to allow you to effectively lead a cross-functional team. CPM team in PPV as leading CRO n Iran also be familiar with the financial aspects of a clinical study, including reviewing invoices, performing daily accounting tasks and budgeting. In some cases, the clinical project manager’s jobs may include contributing to statistical analysis and reporting data used to support marketing approval or marketing registration.

Plan: Review of the project charter development of a project plan:

It is widely acknowledged that planning, organizing, prioritizing and creating criteria in a project are prominent. Nevertheless, they can be easily neglected. In order to establish a regular policy, PPV team emphasizes the need for regular checklists which can guarantee the process of conclusion.

Mapping: creation of the process maps from trial planning

In this section, the PPV(CRO in Iran) clinical trial experts begin designing a protocol based on the criteria for the study, the time period for studying, dosage and ways to use the drug. These protocols are sent to the Ethics Committee and the competent authorities, after verifying the approval, the project authorities enter the implementation phases.

Tracking: Defining project scope; identification of critical path to a project

At this stage, the PPV team begins to prepare the site for studying and patient recruitment. The costs of delaying patient registration are not only high but also difficult. Prediction and control of regulation are constantly being updated. Newly developed methods that make clinical studies available to patients and researchers and the right choice of service providers to enter patients, has made it difficult for patient recruitment in many parts of the world. Since delaying the patient enrolment process has a number of negative effects on the clinical study, we promise to work ahead of the “time crunch” to avoid them. In fact, PPV as a leading CRO in IRAN offers a high level of specialized services in the field of CPM by providing universities, institutes and research centers, laboratories and various pharmaceutical industries with research and commercial services.

Medical Writing

PPV offers a complete writing service spanning from individual documents to extensive medical writing programs. Our efficient and experienced medical writing team is diligent to provide our client with documentation in full accord with ICH guidelines that will help to realize their regulatory and marketing goals. We have proficiency to communicate complex clinical data in a concise and unambiguous manner. * Study protocols * Amendments, and administrative changes * Final study reports * Medical paper

Monitoring

Our in-house operational personnel are based globally and throughout the Asia region. We aim to limit travel, bolster support for project teams and importantly leverage local knowledge of the clinical research and regulatory environments. PPV offers an experienced team of regionally based monitors, all with top in class oncology, chronic disease and monitoring experience. Our global clinical research associates (CRAs) focus on developing strong site relationships while ensuring adherence to data quality, subject safety, and early issue resolution throughout the course of the trial. Regular site monitor visits can be broken down into three types: initiation visits, periodic monitoring visits, and close-out visits.

Initiation visit:

A Site Initiation Visit (SIV) is when the research study team receives adequate training from the sponsor or CRO on the protocol. It is also the opportunity for the sponsor or CRO to ensure that the investigator fully understands his/her responsibilities.

Periodic monitoring visit:

The sponsor and/or CRO will develop a monitor plan that includes the frequency and duration of periodic monitor visits. The focus of these visits is to evaluate the way the study is being conducted and to perform source document verification.

Close-out visit:

This visit will include: Final consent form review, if needed Verification of required essential documents Completion of data review and source verification Confirmation that UPs/SAEs have been documented in data collection forms and reported appropriately Confirmation that all lab samples have been shipped, as applicable, and appropriately stored

Pharmacovigilance

A broad assessment of drug safety information is pivotal to exceed the success of a clinical study. Through safety monitoring and giving transparent reports, PPV keeps the client well-informed about any change in their drug safety to control their development programs. We provide your projects with comprehensive solutions to maximize success and minimize cost and delays.

Quality and Compliance/Auditing

PPV auditing services includes: Quality and compliance are the primary requirements in every step of a clinical study. PPV leads its experts with the client regarding any quality matters, study status and helping them with all aspects of the audit process. We provide you with timely and systematic audit reports. Furthermore, we are supposed to offered a reasonable explanation for the audit findings, their importance and possible resolutions.

Project audits

Investigator files / site audits

Trial master file audits

Database audits

Statistical report audits

Clinical study report audits

Regulatory submission audits

Process audits

Vendor audits

Regulatory Affairs

Since guidelines play a crucial role in clinical development programmes, it sounds essential to adopt a coherent regulatory strategy plan early in clinical study to recognize any possible challenge that may emerge throughout the process. PPV’s team has the up-to-date information about regional and global regulatory requirements to facilitate the administrative and logistics procedures of conducting a clinical study in compliance with required standards and regulatory authorities.

Site selection/Patient recruitment

Clinical research demands careful consideration of ethical, scientific, methodological and operational aspects. A significant number of clinical trials experience delays, which can extend the duration of a given study by up to 50% of its originally planned time. The reasons for delays are numerous and methods to reduce them must be ensured. Patient recruitment is among the leading causes, which is not surprising if we consider that reportedly many sites will not enroll the number of patients expected at the beginning of the study. Sites unable to recruit enough patients increase the length of the enrolment period and become an economic burden. The time and cost of training, opening and maintaining a site can represent a considerable amount and underperforming sites cannot justify this expense. In addition, sites with insufficient experience are more likely to incur in protocol violations or to have low-quality data that will require further training, on-site visits and more queries for clarification, all of which have an impact on costs and study duration. Choosing appropriate sites able to recruit an adequate number of patients while maintaining high quality data is crucial for timely and successful completion of studies. Several aspects play a role in selecting a site for sponsored multicentre clinical studies. First and most importantly, a site taking part in a given clinical trial must have access to a relatively high volume of patients meeting the eligibility criteria, expertise in the area, appropriate facilities or equipment and trained investigators eager to perform research. In addition, previous research experience of the study site provides an indicator of past performance in recruitment and data quality.

Training

Our professional experience in the field of clinical research as best CRO in Iran collaborate with project staff to provide crucial knowledge and skills. They are available during business hours to answer questions and assist with any training assignments. PPV as best CRO in Iran gives GCP and regulatory trainings to pharmaceutical companies, as well as to researchers.

Protocol development and Validation

When investing in the development of your drug, you need to start from the right place. In the process of designing a clinical trial, the accuracy and precision of an endpoint is a primary factor to determine valid results. In addition, recognizing the barriers to patient recruitment and adopting an effective enrollment strategy play a crucial role in saving money and time. By working with PPV from the start, you can validate your protocols and achieve the accurate results.