Services
Proclintek is a CRO built from the ground up by CRAs to deliver the very best in clinical research.
As a contact point between the sponsor and sites, we integrate all aspects of the clinical trial from start to finish, helping to plan, coordinate, execute, and supervise the processes involved.
Staffing Services
Proclintek offers high-quality contract staffing solutions for life science companies that require support for various aspects of their clinical research. We draw talent from a pool of highly qualified clinical research professionals representing different technical disciplines whom we carefully screen to match with the existing opportunities offered by sponsors. From pre-clinical to clinical to commercial, our recruiters have the capability, experience, and resources to hire and retain the best and brightest talent to build our clients’ clinical research project teams.
To adequately meet our clients’ personnel needs, we maintain and regularly update an extensive HR database ensuring skilled staff are always available to support contract research services. We’re also careful to offer opportunities that create a pathway for career progression, ensuring contract research support staff fulfil their ambitions and life goals.
Our clinical trials staff augmentation services cover Phase I to Phase III stages and include post-marketing surveillance and development.
We also recruit contract staff to cover these role types:
- Clinical Project Director
- Regional Director
- Clinical Project Manager (CPM)
- Clinical Research Associate (CRA),
- Clinical Trials Assistant (CTA)
- Document Specialist
Whether full-time or part-time, Proclintek will always get you the right talent to suit your project set-up.
Looking for CRO staffing services?
Contract research organization services
Site Identification & Selection Services
Proclintek has access to a wide network of clinical research sites which gives us a distinct advantage when advising on a suitable site selection strategy. This is especially critical for medical device studies where an accurate site feasibility assessment is vital.
- We prepare sites for initiation on behalf of our sponsors by conducting training and education which helps speed up start-up timelines.
- We also use industry best practices combined with the latest technology to ensure high-quality sites are selected, improving the delivery timeline, budgetary aspects, and accuracy of findings for the trial.
Your trial deserves the best chance of success.
Find out how we can help you reach your clinical research project milestones faster.
Medical monitoring services & protocol development
At Proclintek, we leverage our business relationships with qualified specialists in different therapeutic areas to improve our medical monitoring services and protocol development process.
We dedicate a medical monitor with relevant skills and experience to support the clinical research study by way of advising on trial-related questions or problems during the development stages of a medical or pharmaceutical product.
A medical monitor is typically an MD or PharmD degree holder with strong leadership skills whose primary responsibilities include:
- Ensuring the safety and integrity of the trial subjects
- Acting as the reference point for study team members and investigative sites
- Giving their input on clinical research plans, as well as protocol design, and risk factors.
- Reviewing all study team objectives
One of the most daunting aspects of setting up a clinical trial is finding a suitable professional to fill the role of a medical monitor. This is where the expertise of an experienced contract research organization like Proclintek comes in handy.
Need the expertise of a medical monitor to oversee the safety aspects of your clinical trial?
Clinical operations
At Proclintek our clinical operations team collaborates with you to plan and design, implement and manage the clinical trial process while adhering to the established global regulatory pathways for successful outcomes. Our highly skilled clinical operations team offers a full suite of patient-centric services to successfully drive various functions of your clinical trials.
These functions include:
- Monitoring – Proclintek provides the expertise of medical monitoring to supervise the safety aspects of your clinical trial while giving input on clinical research plans, protocol design, and risk assessments.
- Data management – Our team members of CDM focus on the generation of first-class, dependable, and statistically sound data from clinical trials which helps drastically cut down on the time taken between drug development and marketing. Our skilled personnel has outstanding process knowledge that is crucial in maintaining the quality standards of this critical phase in clinical research.
- Biostatistics – From trial design to protocol development, biostatistics play a crucial role in the drug or medical device development process. At Proclintek we work with the data management team to design data collection tools, carry out ongoing data quality checks, and team up with our medical writers to prepare the clinical study report.
- Regulatory affairs – At Proclintek we adhere to clinical trial regulations to ensure that clinical studies are done in a transparent manner while observing the highest safety standards. Proclintek helps clients stay ahead of complex and ever changing regulatory requirements by advising on regulatory strategies, leveraging IT resources, and implementing maintenance requirements for products already in the market place.
- Quality assurance – Proclintek ensures that our clinical operations always have a level of quality and ethical standard assurance built into them to safeguard patients’ rights as well as the data that is captured. To this end we always ensure our Source Data Verification (SDV) activities are of the highest standard.
Do you require Clinical Operation professionals to optimize your trial design and support your clinical trial process from start-up to close?
Find out how we can help you reach your clinical research project milestones faster.
Pharmacovigilance
Pharmacovigilance (PV) provides a system to collect, assess, and distribute drug safety data, thereby bolstering patient safety with respect to medicine use. It also helps pharmaceutical companies assess the risk vs benefit of a drug and whether any action is required to improve safety. Proclintek is a highly capable PV services provider that offers safety database solutions as well as intelligent automation resulting in a compliant and effective pharmacovigilance system.
Do you need support for your pharmacovigilance processes – from proof-of-concept to end-to-end services?
Decentralized Trial Systems
Decentralized clinical trials (DCT) provide immeasurable benefits when it comes to recruitment and retention of patients, as well as reduced costs and travel time. However, uncertainty around data integrity can arise when the endpoint data collection is entrusted to clinical study participants as opposed to qualified site staff.
Prolclintek’s scientific capabilities, reach and purpose-built platform ensure that clinical evidence in your DCT is delivered with the accuracy and reliability that is required.
Our DCTs will help you engage the right patients wherever they are.
Looking for CRO staffing services?
Study Start-up solutions
Study start-up is an important phase during clinical research project initiation where the aspects of quality, cost, and site activation timelines need to be carefully managed for successful outcomes.
Our Start-up teams at Proclintek work closely with the industry’s top therapeutic and regulatory experts to deliver a customized approach that is well-coordinated, ensuring study start up is accelerated.
For start-up times that are quicker than clinical research industry averages, consult with Proclintek.