Sofpromed (United States)

Sofpromed is a full-service Clinical Research Organization (CRO) that manages phase I–IV clinical trials for biotechnology and pharmaceutical companies worldwide. Founded in 2012, the company has grown into a trusted partner for sponsors running multinational studies, with a stated global footprint spanning the United States, United Kingdom, Europe, and Australia. Its US operations are headquartered at 882 Patriot Drive, Suite D, Moorpark, California, while its European base is in Palma de Mallorca, Spain, operating under the legal entity Sofpromed Investigación Clínica SL. The company positions itself as a one-stop, full-service CRO. Its service portfolio covers regulatory affairs, ethics committee and competent authority submissions, insurance policies, site selection and activation, site management, clinical monitoring, data management, logistics, pharmacovigilance, biostatistics, medical writing and translations, and project management. Beyond traditional CRO services, Sofpromed also facilitates formulation development, analytical testing, drug manufacturing, labeling, packaging, storage, and distribution solutions for clinical trial sponsors. It offers GMP auditing services covering drug substance/API manufacturers, drug product manufacturers, CMO/CDMO and supplier audits, drug distribution companies, and mock audits/self-inspections. Therapeutic expertise includes oncology, cardiovascular, metabolic, central nervous system, dermatological, infectious, and respiratory diseases, among other areas. In the European Union, Sofpromed operates in key countries such as Spain, France, Germany, Italy, the Netherlands, Poland, the Czech Republic, Slovakia, Greece, and Georgia. The company also provides a Clinical Trial Cost Calculator tool to help sponsors estimate budgets. Sofpromed's leadership includes Patricio Ledesma, who serves as Chief Executive Officer and Global Director of Clinical Operations. The company emphasizes a deep commitment and personal dedication to each client and the success of their clinical development programs. With contact numbers for the USA, UK, and EU, and a team distributed across North America, the United Kingdom, Europe, and Asia-Pacific, Sofpromed presents itself as a globally oriented CRO serving the clinical trial needs of sponsors around the world.

Sofpromed was founded in 2012, according to its corporate message, with the goal of becoming a trusted Clinical Research Organization (CRO) for biotechnology and pharmaceutical companies conducting clinical trials around the world. From its early years, the company adopted a distinctive one-stop full-service approach, aiming to provide clients with effective solutions to all their clinical trial needs — not only regulatory, clinical operations, biometrics, drug safety, and medical writing services but also drug development, manufacturing, and trial logistics support. Over time, Sofpromed expanded its geographic reach. It established a presence in the United States, with a US office at 882 Patriot Drive, Suite D, Moorpark, California, and in Europe, with an office at Camí Vell de Bunyola 37B, 1st Floor, Office 7, 07009 Palma de Mallorca, Spain. The European operations are conducted under the legal entity Sofpromed Investigación Clínica SL. The company also maintains a UK contact number and states that it manages clinical trials globally in the United States, United Kingdom, Europe, and Australia. Within the European Union, it operates in key countries including Spain, France, Germany, Italy, the Netherlands, Poland, the Czech Republic, Slovakia, Greece, and Georgia. Sofpromed's service portfolio has grown to cover the full clinical trial lifecycle. Its regulatory affairs team handles ethics committees, competent authority submissions, and insurance policies. Clinical operations include site selection and activation, selection visits, site contracts, initiation visits, site management, communication with sites, quality control, progress reports, and monitoring with onsite visits, source data verification, and CRF review. Data management services include eCRF/DB design, data cleaning, and query resolution. Logistics management covers biological sample shipments, drug distribution, and trial materials. Pharmacovigilance includes SAE/SUSAR management, EudraVigilance, and safety reports. Biostatistics offers sample size, statistical programming, and statistical analysis. Medical writing and translations cover protocols, informed consents, and publications. Project management includes planning and follow-up, quality control, and financial management. In addition to these core CRO services, Sofpromed facilitates formulation development, analytical testing, drug manufacturing, labeling, packaging, storage, and distribution solutions for clinical trial sponsors around the world. It also offers GMP auditing services, including drug substance/API manufacturer audits, drug product manufacturer audits, CMO/CDMO and API/excipient supplier audits, drug distribution company audits, and mock audits/self-inspections, performed by accredited auditors with a high level of independence worldwide. The company's therapeutic expertise spans oncology, cardiovascular, metabolic, central nervous system, dermatological, infectious, and respiratory diseases, among other areas. Its team members are located in North America, the United Kingdom, Europe, and Asia-Pacific. Leadership includes Patricio Ledesma as Chief Executive Officer and Global Director of Clinical Operations. Sofpromed continues to present itself as a full-service CRO dedicated to streamlining the execution of clinical trials and the development of innovative treatments for sponsors globally.

• 2012

  Sofpromed is founded, beginning its journey as a Clinical Research Organization.

• Establishes US office at 882 Patriot Drive, Suite D, Moorpark, California.

• Establishes European office at Camí Vell de Bunyola 37B, Palma de Mallorca, Spain, under Sofpromed Investigación Clínica SL.

• Launches Clinical Trial Cost Calculator tool for sponsors.

• Expands GMP auditing services for drug development.

Full-service, one-stop CRO for global clinical trials with a personal, client-dedicated approach.

• Regulatory Affairs

  Ethics committees, competent authority submissions, insurance policies.

• Site Selection & Activation

  Selection visits, site contracts, initiation visits.

• Site Management

  Communication with sites, quality control, progress reports.

• Monitoring

  Onsite visits, source data verification, CRF review.

• Data Management

  eCRF/DB design, data cleaning, query resolution.

• Logistics Management

  Biological sample shipments, drug distribution, trial materials.

• Pharmacovigilance

  SAE/SUSAR management, EudraVigilance, safety reports.

• Biostatistics

  Sample size, statistical programming, statistical analysis.

• Medical Writing & Translations

  Protocols, informed consents, publications.

• Project Management

  Planning & follow-up, quality control, financial management.

• GMP Auditing Services

  Drug substance/API manufacturer audits, drug product manufacturer audits, CMO/CDMO and supplier audits, drug distribution company audits, mock audits/self-inspections.

• Clinical Trial Cost Calculator

  Tool to estimate clinical trial budget in seconds.

1. 1Full-Service CRO for Global Clinical Trialssofpromed.com
2. 2Sofpromed CROsofpromed.com
3. 3Corporate Message - Sofpromedsofpromed.com
4. 4GMP Auditing Services for Drug Manufacturingsofpromed.com
5. 5Sofpromed (United States) - Wikidatawikidata.org