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Clinical Research Services

Optimizing Clinical Research with Expert CRO and SMO Services

At Priosh PharmaChem AG, we advance clinical research through leveraging the latest AI technology with our Contract Research Organization (CRO) services capabilities and preferred Site Management Organization (SMO) partnerships, resulting in a patient-centric approach with comprehensive site management services for conducting rapid and cost-effective clinical trials. We streamline clinical trials through focusing on site-level operations, patient recruitment, enhancing efficiency across trials, and ensuring regulatory compliance. With expertise in various therapeutic areas, in particular cardiovascular, CNS and oncology, and a strong network of clinical sites, we support trials of any scale.

From assisting with patient recruitment to facilitating communication between sites and sponsors, our goal is to ensure smooth, compliant, and timely execution of every clinical trial.

We streamline clinical trials through focusing on site-level operations, patient recruitment, enhancing efficiency across trials, and ensuring regulatory compliance.

CRO Services

Priosh PharmaChem AG offers a suite of clinical development services enhanced with the latest AI technology, tailored to biotech and pharmaceutical companies, and partners with other CROs. Our role is to bridge the gap between clients and sites, ensuring efficient communication, compliance, and operational excellence in conducting clinical studies.
Our CRO services include:

Strategic Consulting

We provide consulting services for defining the most optimal clinical development strategy for conducting rapid and cost-effective trials.

Clinical Development Planning

We provide services for creating a clinical development plan (CDP) — a comprehensive strategy for developing an investigational product through regulatory submission involving a multidisciplinary team that includes experts in clinical development, regulatory affairs, medical affairs, statistics, and other relevant areas.

Medical Writing and Protocol Design

We provide services for designing and testing optimal patient-centric study protocols through leveraging the latest AI technology capturing the patient voice.

Clinical Trial and Project Management

We commit to delivering your clinical trials on time with the highest quality of data through rigorous project management leveraging the latest AI technology resulting in rapid and cost-effective trials.

Site Feasibility and Selection

We conduct thorough feasibility studies to identify the best sites for your specific clinical trial needs. This includes assessing the site’s patient population, available resources, and track record in clinical research.

Study Start-up Support

We expedite the start-up process by coordinating site activation, negotiating contracts, and ensuring that all regulatory documents are in place before the trial begins.

Clinical Monitoring

We provide ongoing monitoring and oversight of sites, ensuring that they meet study timelines, enrollment goals, and compliance requirements. This includes regular site visits, communication, and issue resolution.

Regulatory Compliance

Our team ensures that all sites adhere to local and international regulations, including FDA, EMA, and other governing bodies. We manage essential regulatory submissions and updates throughout the trial.

Medical Monitoring

We provide qualified physicians who oversee the medical aspects of clinical trials ensuring the safety and well-being of trial participants throughout the duration of the study.

Data Integrity

We ensure the integrity of trial data by providing continuous monitoring and quality control. This involves verifying that site staff are following protocols and that all data is collected, reported, and stored according to GCP standards.

Budget and Contract Negotiation

We manage all financial aspects of the trial, from negotiating contracts with sites to managing payment schedules and ensuring cost-effectiveness without compromising quality.

Quality and Compliance

We handle any issues that arise during the trial, including deviations from protocol, patient-related concerns, or site-specific challenges. Our proactive approach ensures minimal disruption to the study.

By offering these services, we help our clients optimize trial operations, reduce risks, and ensure trials are conducted efficiently and within budget. Our deep industry knowledge and operational excellence ensure that we are a trusted partner in clinical research.

SMO Services

Priosh PharmaChem AG offers a wide range of SMO services, specifically designed to support clinical research sites. We focus on ensuring that each site is equipped to conduct trials effectively and meets regulatory and operational standards.
Our SMO services include:

Site Selection and Qualification

We help identify and select sites based on their capability to successfully conduct and meet the specific criteria required for clinical trials. Our thorough qualification process ensures that only the most appropriate sites are chosen. Additionally, we assist in obtaining Institutional Review Board (IRB) approvals, which are critical for ethical compliance in research.

Investigator Support

We offer ongoing support to principal investigators and research teams, providing guidance on clinical protocols, study management, and compliance.

Patient Recruitment and Retention

Patient recruitment is critical to the success of any clinical trial. We assist sites in developing and executing patient recruitment strategies, improving enrollment timelines, and ensuring patient retention throughout the study.

Regulatory Compliance and Documentation

Our experts help sites navigate the complex regulatory landscape, ensuring proper documentation, adherence to Good Clinical Practice (GCP), and meeting all ethical standards.

Training and Education

We provide comprehensive training to site staff on study-specific protocols, regulatory requirements, and best practices in trial management.

Site
Monitoring

Continuous monitoring is crucial for maintaining the quality and integrity of clinical data. We provide regular site visits and remote monitoring to ensure adherence to study protocols and data accuracy.

Budget Management

We assist sites in managing the financial aspects of clinical trials through budget and contract negotiations with clinical investigators, ensuring fair and timely compensation while setting clear expectations for their involvement in the research.

By providing these tailored services, we empower sites to focus on delivering quality patient care and accurate trial results, without the burden of administrative challenges.