Since 2001, XEsearch Clinicals has been polishing and enhancing the scientific validity of our analgesic clinical studies. We are the premier analgesic CRO with over 350 completed pain trials, 10 analgesic FDA approvals, 80 years of scientific support for pain research, 12 favorable FDA audits with no 483s issued, and teams who have only ever worked with analgesics.

Project managers with the necessary skills to handle analgesic studies are available from XEsearrch Clinical. Our project managers have extensive experience in pain trials, with an emphasis on driving studies to on-time completion with the highest quality data to support regulatory filings. With an average tenure of 10+ years in the sector.

Our project managers are quite skilled at quick starts. Projects have been launched in as little as six weeks by utilizing XEsearrch Clinical’s analgesic expertise and collaborative approach, from final protocol to first patient in.

Our databases are set up with the aim in mind—appropriate calculation of analgesic primary and secondary endpoints—while also accommodating the unique configuration necessary for analgesic report outputs.
Time is of the essence when interim analysis is necessary. Biostatisticians can quickly and effectively retrieve the data needed by the interim analyses thanks to precise, well-organized data output. To make sure that any hitches can be worked out before “crunch time,” we conduct test exports and analyses of dummy, protocol-specific data well before interim analyses take place.

XEsearch Clinical monitors are familiar with analgesic charting for both inpatient and outpatient patients, including notes on anesthesia and surgical procedures. Additionally, monitors receive training in administering analgesic questionnaires and reducing placebo response. They can effectively impart this knowledge to site-level workers thanks to exclusive training materials created by Lotus.

The specialized team of monitors at XEsearch Clinical commits to provide exceptionally high-quality data assessment while actively participating in the trial locations. Throughout the duration of the study, our monitors conduct on-site clinical trial monitoring visits to supervise data collection, examine clinical laboratory results, source documentation, and electronic/paper case report forms, address data queries, and check regulatory compliance.

XEsearch, a company that has focused on analgesic research since 2001, has collaborated on numerous occasions with locations that have experience with common pain models, including: dental extraction, bunionectomy, abdominoplasty, Delayed Onset Muscle Soreness (DOMS), Opioid Induced Constipation (OIC), knee replacement, hip replacement, soft tissue surgery, chronic lower back pain, osteoarthritis, postherpetic neuralgia, and Diabetic Peripheral (DPN).

XEsearch Clinical continuously assesses each site’s performance to achieve site excellence, not just by monitoring enrollment and evaluating data quality but also by quantifying scientific outputs. We only collaborate with websites that have a track record of discriminating between effective medications and placebos.

Our biostatistical staff members offer more than just data analysis; they are well knowledgeable about the methodology for researching analgesic drugs and how to assess the findings from such studies.

Data from analgesic trials have been processed and analyzed by XEsearch Clinical biostatisticians for years. They are well-versed in the Division of Anesthesia, Analgesia, and Rheumatology Products’ (DAARPs’) position on analgesic data imputation, including MMRM, LOCF, BOCF, and WOCD, as well as more sophisticated Rubin multiple imputation techniques, and they have written a number of Statistical Analysis Plans (SAPs).

The team of skilled doctors and nurses at XEsearch Clinical is committed to provide our subjects a network of support. Lotus Clinical Research offers a 24-hour safety service for our clinical studies in order to provide this level of support.

Because participants in analgesic trials typically have considerable continuing pathology, they present a special problem (chronic disease states in the case of chronic pain trials and postsurgical morbidity in the case of acute pain trials). As a result of their familiarity with the normal pathophysiology of participants in analgesic trials, XEsearch Clinical’s medical monitors are better able to appropriately assess these investigations.

Clinical and regulatory writing strategies are both familiar to XEsearch Clinical medical writers, who produce clear documents that go above and beyond customer expectations. To ensure that publications are thorough and accurately reflect our high standard of scientific rigor and patient care, our writers collaborate closely with our biostatisticians and peer reviewers. Additionally, the highly collaborative approach of XEsearch Clinical ensures well-formed documents that take into account client preferences, regional laws, and requirements.

For various pain models, we have created a number of templates for protocols, ICFs, patient diaries, and other deliverables. We can quickly and accurately prepare critical documents using these carefully vetted analgesic templates.

The quality management team at XEsearch Clinical assists our internal teams and clients in producing papers that adhere to regulatory and protocol criteria. The development of policies, reports, and/or training materials that contribute to the protection of study participants is supported by our quality managers.

In order to execute trials in the safest and most effective manner possible while adhering to all local and regulatory requirements, our team offers research recommendations and enhancements. To verify site compliance with the protocol and federal standards for multicenter studies, XEsearch Clinical quality managers can call upon a group of highly skilled auditing professionals to conduct GCP-focused site audits.

For sponsors, XEsearch Clinical offers documentation services for ethical committees. To provide the services listed below, our teams rely on a wealth of internal resources:

Trial Master File (TMF) services, regulatory document collection from participating clinical trial sites, startup quality evaluation, and safety reporting.