We are aware that there isn’t a single, universal approach to decentralizing clinical trials. To bring clinical trials closer to the patient, our committed Decentralized Solutions team combines completely integrated clinical, RWE, and commercial insights, agile technologies, and operational expertise. Our creative trial design know-how generates fresh approaches to hasten patient access, enhance retention, and broaden diversity.

We’ll designate you a single point of contact because your happiness is our top priority. This person’s responsibility is to communicate with you promptly and ensure that your criteria are met during the whole life of your project. In order to do this, all of our teams who perform bioanalysis adhere to the most recent GCP and GLP standards (GLP).

We Keep Our Promises

Our bioanalytical services are focused on keeping our promise to complete projects on time while maintaining high standards of quality and compliance. We understand your requirement for a speedy turnaround, thus method development and proof-of-concept may frequently be completed in a matter of days, allowing for swift yes-or-no choices.

Our CRO has a vast and varied capacity.

Regardless of the size of your project, we approach bioanalytical services with a “full capacity” mindset. We offer bioanalytical services at all stages of drug development through our GLP-compliant laboratories, a wide variety of validated assays, custom assay services, educated scientists, and competent technicians.

Then, we combine our extensive knowledge of peptides, immunochemistry, LC/MS/MS, HRMS, GC/MS/MS, and ICP-MS with cutting-edge research and effective, verified procedures.

A crucial development milestone on the path from the lab to life is the collection of initial human data.

Our expert Early Phase team has spent more than 25 years developing strategies for navigating this difficult stage of clinical research.

Complete Service Customized Solutions, from A to Z

We can carry out any preclinical, Phase I to Phase IIa study, including first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), organ impairment, thorough QT (TQT), biosimilar, and numerous pharmacokinetic (PK), single ascending dose/multiple ascending dose (SAD/MAD) studies.

Additionally, we have extensive expertise working with a wide range of investigational products (IPs), including those with biological origins, as well as with various delivery techniques. Additionally, we have access to particular patient populations, such as Japanese, Chinese, geriatric, or obese individuals.

Patient recruiting, risk management, and data monitoring… We are aware of the difficulties that your Phase II and Phase III clinical trials pose. Regardless of the therapy area or location, we can offer the services and solutions you need for your trial to be successful thanks to our decades of experience.
It’s crucial that protocol and recruitment strategies are thoroughly and early evaluated to avoid expensive delays given the regulatory authorities’ rising demands for clinical data, the complexity of protocols, and the difficulties in enrolling patients and investigators.

We can assist you in determining the best course of action to save costs and risks, verifying whether your protocol complies with international standards, and choosing the ideal locations. We’ll also assess the results of competitive trials, improve patient access, and offer insightful analysis of your recruitment difficulties.

Clinical research at the late stages (Phase IIIb–IV) is carried out for purposes distinct from pre-approval studies. Success after clearance is dependent on documentation, persuasive safety and value communication, and an operational strategy that takes into account the special traits of late phase research, including their objectives, metrics, stakeholders, and time constraints.

Utilizing Global Resources and Our Specialized Perspectives to Meet Your Late-Stage Goals

We have unique insights into the organizational dynamics that affect a late stage endeavor thanks to the depth of our experience and services. Consensus and clarity are thus provided to our customers, resulting in extremely productive research projects that frequently start well before product clearance. Our customers gain from attaining both commercial and scientific success through a balanced and financially practical strategy that acknowledges the unique needs of each.

The secret to commercial success in biopharmaceutical development is crafting a compelling value story. As payers, physicians, patients, and, increasingly, regulators come to appreciate the significance of the data made available by RWE, Real World Evidence (RWE) provides the groundwork for that story.

The crucial transition from clinical efficacy to a commercially successful brand is made possible by RWE generation. Clinical and business disciplines collaborate at XEsearch Research exchanging ideas and expertise. In the course of medication development, it is never too early to take commercialization into account. In order to design, produce, and deliver fully integrated Real World Evidence that is prepared for the peri-approval context and gathers the necessary data to guarantee launch success, we are committed to collaborating with you.

Research on medical devices and diagnostics is a big and getting more complicated field. Our knowledgeable and skilled team makes sure that research on your products produce data that will support their approval. We have a professional business team with expertise in this field that can help you from concept to market.

There are requirements specific to medical device and diagnostics that must be met when bringing items from concept to market. Your product, unlike drug development, is a “innovation” that may be improved if there is proof to back up design changes. In order to improve your product, we have carried out more than 400 research in this field with a focus on customer input.

We Have the Knowledge You Need to Complete Your Medical Device and Diagnostics Trial Successfully

All stages of clinical development and commercialization are supported fully by our biostatistics and statistical programming expertise. Our knowledgeable biostatisticians and statistical programmers are spread out over the world and are trained in the most recent techniques and guidelines to enable the efficient completion of your projects.

We make use of our internal Biometrics Innovations and Biostatistics Consulting teams to deliver technical know-how and efficiencies to projects of all kinds, from modest first-in-human studies to huge international ones. Additionally, we provide a Functional Service Provider (FSP) paradigm for services in statistical programming and biostatistics.

We have had success using the FSP approach across a variety of disciplines through long-term collaborations, a variety of dynamic delivery methods, and numerous locations with hundreds of biostatistics FTEs.

Actual Readiness
We aim for real-time preparedness and support data transparency. To keep our clients informed of the project’s progress and performance, we employ cutting-edge methods and technologies for tracking and reporting data quality and progress. Every step of the process includes quality and risk management, and our technology-enabled model makes it possible to identify risks and concerns early, feed important information to the project team, and adopt an adaptive strategy for monitoring and trial delivery.

Global, adaptable, and dependable

We offer 24-hour time zone coverage thanks to our established infrastructure and widespread presence through our data management centers in the United States, Mexico, Europe, India, China, and Japan.

Model FSP

We can provide strategic and collaborative solutions through an FSP, delivering levels.

You will only need to work with one person on each CDS project since our Clinical Development Services (CDS) Project Managers offer solution-focused project management across our single, multiple, full service, FSP 360, and Full-Service CDS business lines. All non-therapeutic Business Unit-specific areas, from Early Phase to the assistance of regulatory submissions, are supported by our CDS Project Managers.

Our clinical project management solutions offer specialized support for CDS-only work from Early Phase through Phase IV, as well as experienced Project Managers for safety and pharmacovigilance portfolio work, ensuring consistency across programs and submissions and covering all therapeutic areas and indications.

Worldwide trials are monitored by our devoted Clinical Research Associates, CRAs, and CMAs. Each CRA specializes in a single therapy area, giving them in-depth familiarity with the patients, research sites, and particular difficulties involved. All members of the Clinical Trial Monitoring team undergo regular training to keep them fully up to date with the latest rules, procedures, and technologies. Our ground-breaking Central Monitoring and Global Clinical Operations Management (GCOM) groups assist them.

For CRAs at all levels, thorough training and support are essential. To make sure that our CRAs are always informed of new methods and technology as well as any legislative changes, we offer training through the CTI. Over time, our CRAs establish a positive connection with the site workers and gain a thorough understanding of the difficulties.

Worldwide clinical trial and post-marketing safety surveillance is supported by our safety and pharmacovigilance teams. Patient safety is a crucial consideration in product development, and our quality focus enables us to collaborate with our clients to offer both standalone and integrated services over the course of a product’s life cycle.

Our employees, who are highly qualified drug safety scientists and skilled healthcare professionals with experience in providing direct patient care, sector-specific pharmacovigilance services, in-depth knowledge of regulatory legislation, and a commitment to offering high-quality safety services, are what make us unique.

One of the biggest safety and pharmacovigilance teams in the business is at your service, operating globally.

Streamlining the Clinical Trial Payment Process to Benefit Customers and Sites

Through meeting or exceeding enrollment targets and lowering costs, we are committed to ensure that our customers receive the high-quality clinical research data they need to deliver medical therapies to patients more quickly. The clinical trial payment process must satisfy investigative sites, and we do this by automating it, providing industry-leading transparency reporting capabilities, and integrating data management and site contracting.

Finding the Main Pain Points on the Investigator Site

We introduced the first worldwide SAG in December 2015 with SCRS (the Society for Clinical Research Sites) (Site Advocacy Group). This group, often known as the Investigator Payment (IP) SAG, is entirely concerned with streamlining and enhancing the payment procedure for clinical trial sites.

Across a wide range of therapeutic areas and document kinds, from preclinical reporting through the drug development life cycle to post-marketing and commercialization writing, we offer top-notch medical writing skills.

Our writers handle writing projects, create publications with a consistent tone and message across a range of consumers using data sources and different analytic models. They assist projects with several client contributors and outside thought leaders and have great project management and negotiation skills. To produce uniform, scientifically integrated materials and reduce unnecessary customer oversight, they set timetables, plan and oversee authorship meetings, and reconcile sponsor comments across functions.

With unmatched scientific, technical, and procedural assistance, our clinical Rater Training Services team offers experienced, thorough rater evaluation, rater training, and rater scales management services.

To improve the validity and reliability of outcome assessments for your clinical trials, we combine extensive international expertise with a flexible, client-centered methodology. We work with clients to customize services to the particular training requirements of each individual study. We provide extensive, cutting-edge, full-service capabilities for creating and implementing rater training programs.

For rater education, rater assessments (Central Rating Review), document management (translations, harmonization, copyrights, workbooks), and computerized neuropsychological assessment in multi-center clinical trials, look to us as the undisputed authority.

Our team consists of assessment experts, psychometrists, neuropsychologists, and clinical psychologists with a wealth of international expertise.

In order to cover all facets of SSU and regulatory operations, including Ethics Committee/Independent Review Board submissions, Regulatory Authority submissions, site contract negotiation, and the corresponding oversight of those activities, we have established a dedicated Business Unit with over 1,000 employees.

One of the trickiest and most tightly controlled phases of any clinical trial or program launch is the SSU. A sizable number of stakeholders, including vendors, regulatory agencies (RA), ethical committees (EC), start-up sites, and the Sponsor, are involved during this time.

For this reason, any accelerated project timeframes require early engagement, crystal-clear communication, and effective planning.

Regulatory agencies are requesting an increasing amount of clinical data. Protocols are getting more complicated, and finding qualified investigators and patients is getting harder. Early and thorough protocol and recruiting strategy evaluation can help prevent expensive errors in this environment. In order to create customized “delivery prescriptions” for each clinical project, our information-driven approach to Site and Patient Access combines unique patient insight data from a variety of providers, including medical claims, EMR, social listening, and performance data. This can lead to a project being delivered predictably and effectively when combined with our Catalyst Site delivery methodologies.

Our company strategy places a lot of emphasis on assisting site and patient stakeholders. We value our reputation with clinical research locations highly.

The TMF Process is Managed by Our Skilled, Committed Team with a Focus on Quality and Compliance.

We’re here to help assure the success of your trial with the support of our reliable TMF infrastructure and skilled people who have the necessary training and expertise in TMF processing. Processing TMF papers accurately, thoroughly, and on time is one of the most crucial services we offer.

Each member of our TMF processing team undergoes in-depth document identification training, quality testing, and has vast expertise in the TMF business.

Meeting Your TMF Needs with Quality Using Proven Process and Technology Solutions
To ensure prompt, complete, and correct processing of TMFs, we have spent more than a decade creating procedures and technological solutions.