Full Service Solutions


Regulatory

With offices across the globe, the regulatory affairs team at Pharm-Olam International is an experienced and effective liaison for the coordination and preparation of complex multi-national submissions with all major regulatory authorities. Pharm-Olam has full time regulatory specialists in Belarus, Brazil, Czech Republic, Georgia, Germany, Mexico, Poland, Russia, Serbia, Slovakia, Spain, South Africa, Ukraine, United Kingdom, and the United States. In each of the other countries where Pharm-Olam operates, our Clinical Operations Managers (the majority of whom are MDs or PhDs) execute regulatory tasks locally with support from a full time regulatory specialist who is familiar with their region.

Pharm-Olam provides regulatory consulting as a customized stand-alone service or through our full service clinical trials. Our regulatory professionals ensure client satisfaction through streamlined procedures that provide rapid turnaround of tasks, enabling faster start up, and compliance with applicable guidelines. We can advise sponsors with strategic planning, development, evaluation, and preparation of regulatory submissions at all stages of development and post-marketing. We integrate regulatory and clinical development plans to our sponsor's pipeline strategies by performing regulatory documentation and CMC review, audits, as well as gap assessments to ensure submissions conform to the quality standards of regulatory authorities.

Pharm-Olam can provide assistance with any of the following activities:

  • Clinical trial activation and maintenance
  • Regulatory consulting and strategy planning
  • Formal regulatory meetings with Regulatory Authorities

"The expertise of Regulatory Management ensured that the Authorities received comprehensive and adequate replies on their requests in time." - Medical Director

Project Management

At Pharm-Olam, we believe that constant communication with our clients is the key to our success. Pharm-Olam works closely with our clients to identify and implement solutions to support every trial’s unique needs, even when priorities change during the project.

  • Quality – Ensuring that all facets of each study is completed with high quality results at every step
  • Timelines – Working closely with the study sponsor, ensuring that all project timelines are met to keep the project within the assigned parameters
  • Budget – Working closely with the study sponsor to ensure that the study is completed within budget and eliminate costly change orders

On each project managed by Pharm-Olam, we assign members of our Senior Management team to provide insight and support to our Project Managers throughout the execution of projects, and to liaise with our Sponsors.

Review of our past successes has shown that increased lines of communication between Pharm-Olam and the study sponsor significantly reduces queries and timelines while creating a lasting relationship to benefit future projects. In fact, Pharm-Olam has an 82% repeat business rate and over 50% of our new accounts have been referred by existing clients.

"Project management was of a very high standard and the level of communication with the team was excellent, consequently we were kept extremely well informed."

Clinical Operations

Pharm-Olam’s experienced Clinical Operations team is here to support your program’s needs. From study start-up to the study close out meetings, Pharm-Olam’s staff is here to help you maximize project performance, collect high-quality data, and to help ensure product safety.

To guarantee that your study is managed as efficiently and effectively as possible, Pharm-Olam’s employs experienced CRAs average 6+ years monitoring experience globally and in emerging markets the majority of our staff are physicians or PhDs. Our strategic resource deployment includes offices and field staff in densely populated cities, resulting in less travel time and fewer associated costs throughout the study duration. Pharm-Olam also enjoys a flat organizational structure. This allows for quick decisions and immediate involvement of our senior management team, who are involved from proposal creation, through study handover and during the entire life of the study. We use performance-based metrics, which allow for transparency of information through our CTMS, at all stages of the study, enabling prompt action on study issues and ensuring that timelines and budgets remain on track.

 

Patient Recruitment

Pharm-Olam accelerates patient enrollment through our global network of experienced investigators, patient databases, screening staff, and strategic advertising to ensure studies start on time. We accomplish this by selecting the best performing sites for our sponsor's study. Because the cost of retaining a patient is significantly less than recruiting a new one, patient retention is a top priority. Our strong relationship with clinical sites around the world enables us to conduct rapid feasibility studies, which shortens both the site selection process and the overall duration of a trial.

"The recruitment challenges were considerable, and we asked Pharm-Olam to double their enrollment numbers half way through the trial and still meet the original timelines. The team successfully met this challenge." - Manager, Respiratory Medicine

 

Feasibility

Pharm-Olam specializes in global patient recruitment. We start by accurately identifying target patient populations through feasibility assessments and by implementing cost-effective strategies and tactics to complete enrollment on time. Due to time constraints and high cost of delays commonly encountered in clinical trials, feasibility research is essential to planning a clinical trial. Our recommendations, based on feasibility analysis, have saved sponsors millions in clinical development costs through enhanced protocol design modifications and reduced recruitment periods. Our feasibility research provides specific insights into enrollment, screening failure/completion rates, and retention.

Pharm-Olam’s Country Operations Managers play a key role in the feasibility process. Our Country Operations Managers have excellent contacts with sites in their respective countries and these relationships ensure accurate and meaningful responses to feasibility questionnaires. Furthermore, our Country Operations Managers are senior operational staff that provide unique insight into the distinctive environment of the country they represent, which is a valuable resource for our clients.

"We asked Pharm-Olam to explore studies in two therapeutic areas. Within two weeks, we had a detailed analysis of feasibility of both the regulatory and clinical paths for our programs." - Medical Director

 

Rescue Enrollment

Pharm-Olam has extensive experience in providing supplemental enrollment services. Our experience in many Eastern and Western countries allows us to supply patients in a faster and cost-effective manner when compared to many other areas of the world. Pharm-Olam also can provide access to difficult-to-find patients including pediatrics, treatment-naive populations, seasonal allergy and many more!

To learn more about our supplemental rescue services, visit our Rescue Studies page.

 

Key Opinion Leaders and Investigator Identification

Pharm-Olam has long-standing relationships with many experienced Key Opinion Leaders (KOL’s) and Investigators which ensures that your study has the highest-quality personnel and resources available. Our Investigator identification process allows us to target Investigators with qualified subjects based on feasibility and study protocol, to quickly secure confidential disclosure agreements, collect current critical site information, foster initial communication with site contacts and present the final site list for initiation of site start-up activities.

Pharm-Olam also ensures that a site start-up team consisting of highly specialized and focused staff members that are dedicated entirely to getting the Investigators approved to receive investigational product and begin enrollment. This allows for fast track completion of Investigator regulatory documents, IRB/IEC approvals and Investigator training. It also allow us to clearly define milestones ensuring that all parties are on the same page and that everyone is working together to achieve study success.

 

Site Management

Past experience has proven that working closely with sites is vital to clinical trial success. Our teams work hard to foster excellent relationships with sites to offer support and motivation resulting in efficient and timely studies.  Pharm-Olam has an extensive global network of known sites that have delivered quality results in all therapeutic areas and we are intensely focused on qualifying sites that are able to achieve rapid start up and meet projected enrollment within required timelines.

To ensure a smooth site selection process, Pharm-Olam will perform an extensive feasibility review, which will allow us to place this study in appropriate countries with applicable patients. Once potential sites are identified, we will discuss enrollment timelines with the sites during the selection process and throughout the enrollment period to ensure a reliable action plan for future efforts. This allows us to “build a picture” of potential subjects for the site prior to study start.

Did you know that Pharm-Olam is often asked to provide supplemental site management and patient recruitment services? Visit our rescue page to learn more!

"…we would like to grant our appreciation for fruitful cooperation in frames of [a recent Clinical Trial]. The successful team work of CRO and site staff allowed for positive results including: successful CT conduction, real patient aid and a FDA inspection with no findings. That was a great collaboration and we enjoyed working together." - Head of Department Of Orthopedics And Traumatology

 

Need Drug Storage and Distribution Services? Read about our capabilities here.

Medical Affairs

To support your clinical trials, Pharm-Olam’s Medical Affairs team is available to assist your development programs through a variety of services including:

  • Medical Monitoring
  • Pharmacovigilance
  • Medical Writing

Pharm-Olam’s Medical Affairs team works closely with you to ensure the overall safety and integrity of your trials. Our complete service solutions begin with providing input and guidance into protocol designs and extend the project lifecycle to the final datasets and Data Management Committee or Data Safety Monitoring Boards.

"Pharm-Olam's medical team provided truly expert service and worked very professionally with our in-house Pharmacovigilance personnel." - Executive Vice President, Regulatory Affairs and Clinical Operations

 

Medical Monitoring

Pharm-Olam’s experienced Medical Monitoring team ensures the overall safety of the clinical studies while maintaining medical and clinical integrity, ensuring quality clinical study results. Our Medical Monitors are an integral part of the study team; they work closely with study team members and study Investigators by providing medical leadership and support. Our Medical Monitors are responsible for oversight of investigational drug/device safety, data review and any medically related activities of clinical trials conducted by Pharm-Olam. The Medical Monitor also ensures that the medical/clinical integrity and quality of clinical studies conducted by Pharm-Olam are in compliance with ICH-GCP/FDA requirements.

“And the Pharm-Olam Monitoring Team served as our eyes and ears out in the field. They were key in ensuring the trial was executed with precision and the data obtained was top-quality. Not only did they monitor, but they served as excellent ambassadors on our behalf to support the sites in whatever capacity needed. They educated the sites; they motivated their sites to ensure they met study timelines; and they kept them on task and on target! Each member of the monitoring team represented our interests as if they were their own.” - Global Clinical Trial Manager

 

Data Monitoring Committee (DMC/DSMB) Management

Pharm-Olam has extensive experience in setting up and interacting with Data Safety Monitoring Boards (DSMB) or similar committees (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee, etc.) in most market markets. These activities range from generating DSMB charters, selection of experts in specific therapeutic areas, assembling DSMB members, and extending to full participation in DSMB meetings (open and closed sessions depending on the level of Pharm-Olam involvement). Pharm-Olam Medical Monitors are actively involved in discussions regarding any safety concerns, potential medical alarm signals and investigation of individual patient’s cases as defined in DSMB Charter.

Should you require assistance in DMC / DSMB management, contact us to take advantage of our expertise.

Pharmacovigilance

Pharm-Olam’s experienced Pharmacovigilance (PVG) team of Pharmacovigilance Officers (Physicians) and Drug Safety Officers (DSOs) provides global, full service, Medical and Safety support throughout all phases of clinical development.

Our pharmacovigilance experts specialize in managing all phases of clinical trial AEs and SAEs, including initial receipt, case processing and follow-up, medical review, and closure.

Our services include:

  • Expedited safety reporting
  • Responsible person(s) for EudraVigilance
  • Safety database support using ARISg
  • Preparation of regulatory updates; i.e. PSURs, PADERs, DSURs, etc.
  • Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction
  • Post-Marketing PVG services

We stay current with industry best practices and mandatory regulatory reporting requirements. Our focus allows us to provide solutions tailored to individual client needs. We deliver flexible, client-driven solutions to mitigate risk and ensure regulatory compliance.

Learn how the Pharm-Olam Team Gets Treatments to Market with our Quick Study Article on our Pharmacovigilance services.

Medical Writing

Pharm-Olam’s team of experienced medical writers is responsible for producing comprehensive clinical study documentation that is fully compliant with ICH and GCP guidelines. We offer a broad range of medical writing services, including:

  • Study protocols
  • Investigator brochures
  • Patient information leaflets
  • Informed consent documents
  • Operating procedures
  • Safety update reports
  • Regulatory dossiers
  • Medical publications
  • Interim and fully integrated final clinical study reports

Pharm-Olam Medical Writers work closely with relevant project team members to ensure timely and efficient delivery of all trial materials. Documents generated by Pharm-Olam undergo stringent clinical, medical and statistical review, thus ensuring the highest-quality final product. We deliver easy-to-understand, well-organized, and regulatory-compliant documentation-providing significant cost and time savings to sponsors.

Data Management

Flexible Data Solutions: Let skilled Data Management professionals apply the latest technologies to achieve your study’s objectives.

Pharm-Olam’s Data Management team offers the key to your study’s overall success. Leveraging current applications, Pharm-Olam develops and provides recommendations and systems custom-designed for your study requirements. This ensures a quality data process and the delivery of accurate, complete, and reliable data to support your decision-making processes.

Pharm-Olam's Data Management services include:

  • Accelerated Electronic Data Capture (EDC) start-up time of 4-8 weeks from receipt of a final protocol
  • Electronic Case Report Form (eCRF) design and flexible database systems to allow for staggered deployment of your database
  • Solid processes designed for mid-study updates
  • Globally deployed teams to manage data cleaning, validation, and quality assurance
  • Database deployment to support early decisions
  • Planning and implementation for submission-ready data strategies based on CDISC, SDTM, and ADaM datasets
  • Data programming and standardized tools that facilitate subsequent rapid statistical programming
  • Medical coding in MedDRA and WHO Drug
  • Streamlined reconciliation across multiple internal and vendor-driven data sources (SAE, CTMS, etc.)
  • Functional outsourcing services for data management, with real-time support coverage spanning four different global time zones
  • Substantial experience developing and supporting EDC studies with integrated Randomization and Inventory Management solutions

Pharm-Olam is proud to be offer solutions from these service providers:



 

 

Health Outcomes Research

Our seasoned experts can identify and deliver reliable health outcomes research evidence. We organize and format your product's data clearly for your audience (payers, regulatory authorities, physicians, and other key groups) while maintaining the scientific integrity of the source evidence.

We can provide submission-ready dossiers that convey the value of your product according to FDA/EMA guidelines. Our experts can guide in the selection and analyses of economic and health-related quality-of-life endpoints for studies across all therapeutic areas. We can assist in revealing credible information about the competitiveness of your product to help you with pricing decisions, selection of drug candidates, and reimbursement.

We use novel research methodologies to enhance the quality of analyses that are executed and reported. We provide quality-assured deliverables whether you require strategy documents, economic regulatory dossiers, literature reviews, or reports for peer-reviewed journals.

Biostatistics

Pharm-Olam offers an experienced Biostatistics team that provides biostatistical support and expertise in all aspects of clinical trials. Pharm-Olam’s Statisticians are responsible for the analysis and presentation of clinical data using advanced and cutting-edge statistical methodology. We are available to help with your statistical needs from protocol design to dissemination of results across all therapeutic areas. From full-service project execution to stand-alone services, our experts will collaborate with your team to provide robust analyses, providing you with a solid basis for decision making.

Pharm-Olam’s Biostatistics team can perform the following statistical tasks to support your program:

  • Efficient cost-saving study designs
  • Sample size calculations
  • Randomization services
  • Data Monitoring Committee support
  • e-Submission ready statistical packages
  • SAS Programming support

"The quality of the data and the quick turnaround time for query resolution enabled us to complete the clinical trial and integrated clinical statistical report and meet the aggressive timelines required by this project." - Director of Clinical Operations

Quality and Compliance

At Pharm-Olam, we realize the importance of your development pipeline. Pharm-Olam’s dedicated Quality and Compliance team have extensive experience conducting all types of audits on a global basis. Our team’s hands-on approach and proven processes ensure that you will receive quality data to support your submission to the regulatory authorities.

We utilize a company-wide quality system that uses global quality and escalation policies specifically designed to ensure quality process each and every time. Dedicated QA support to project teams is offered by our QA team members for every project, no matter how large or small.  Pharm-Olam’s Senior Management team leads our commitment to quality, which allows our Quality Assurance team to operate independently, both functionally and financially from our Operational Departments.

Led by an Operational Quality Committee (chaired by QA and made up of all department heads) which meets to ensure all quality procedures are being met and resolves non-project specific CAPAs. Pharm-Olam also maintains a Quality Review Forum, consisting of our entire executive management team, whose function is to provide regular quality review and final escalation of quality issues.

Pharm-Olam can provide assistance with any of the following Quality Assurance activities:

  • Maintenance of Pharm-Olam quality system to assure compliant operations, including management of established Pharm-Olam vendor services (non-billable)
  • Study Specific Audits (Site/ TMF/ CSR)
  • Computerized System Audits
  • Selected Vendor Audit/ Assessment
  • Compliance Assessment (Anti-Bribery, Privacy, International Law)
  • Quality Consulting
  • Inspection readiness/ preparedness
  • Quality training (GCP/ Auditor)
     

"We found the data quality and adherence to the protocol outstanding." - Executive Vice President
 

To take advantage of Pharm-Olam’s experienced team, click here to contact us.