Q&A With Paul Lim: Director, Clinical Research

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - [email protected]

Q&A With Paul Lim Director, Clinical Research

ClinActis is exclusively focused on Asia Pacific, with solid expertise in applying international quality standards to regional specificities. ClinActis is flexible in our approach to work scope and budgeting and contracting process. Delivering Quality to Our Clients ClinActis is committed to implementing international standards in clinical trials. Our ability to deliver high quality results to our clients is based on recruiting and maintaining the best talent within our organization. ClinActis’ senior management is fully accountable for the quality of deliverables to our clients.


Your Proactive Clinical Research Partner in Asia Pacific

ClinActis Pte Ltd is a full service CRO providing clinical trial services to the pharmaceutical, medical device, medical nutrition and biotech companies in Asia Pacific. Established in 2009, ClinActis Pte Ltd is headquartered in Singapore. ClinActis Value Proposition ClinActis is a multicultural company. As such, the team is able to communicate effectively with international clients.


Operational Expertise – Regional Footprint

ClinActis Experience §  33 years experience in clinical

research in pharmaceutical and biotechnology companies as well as CROs

§  27 years experience in Asia Pacific, including Australia/New Zealand, China, Malaysia, Hong Kong, India, Indonesia, the Philippines, Singapore, South Korea, Taiwan, Thailand, Japan and Vietnam

§  Extensive knowledge of regulatory frameworks, best KOLs and sites across the region

§  Vast therapeutic experience including Oncology, Infectious diseases, CNS, Cardiovascular, Endocrinology, and Respiratory

Paul Lim – Director, Clinical Research Paul Lim has 15 years clinical research experience with global pharmaceutical companies and global CROs. He holds a Master’s Degree in Pharmacy (Clinical Pharmacy) and started his clinical research career as a Clinical Pharmacist in the National University Hospital in Malaysia. He later joined an international CRO as senior CRA in Singapore, and another CRO as Clinical Operations Manager. Subsequently, he joined a Biotech company as Regional Clinical Research & Development Manager Asia,


Paul Lim - Director, Clinical Research

Australia, Europe, US, Europe, and Middle-East regions. After this experience, he joined an international pharmaceutical company as Senior Clinical Development Manager Clinical Development, Greater China and Asia. Lastly, before joining ClinActis, he held the position of Senior Clinical Site Manager Asia in another leading international pharmaceutical company. His therapeutic areas experience includes cardiovascular, oncology, endocrinology, infectious diseases, neurology, and respiratory diseases. Paul brings with him a wide breadth of project management and clinical research experience.


Q: Tell Us About the Importance of SOPs and How They Safeguard Clinical Trial Efficiency.

ClinActis is committed to implementing international standards in conducting our clinical trials, regardless if they are multi center R&D studies or local, single-center studies, to ensure the scientific validity of the data we deliver to our clients. Our ability to deliver high quality results to our clients is based on recruiting and maintaining the best talent within our organization, having established operating procedures of international standards and importantly, our ability to adapt our processes to the specificities of implementing clinical trials in Asia based on our in-depth knowledge of the diversity of the cultural and regulatory environment across Asia Pacific. We follow corporate SOPs strictly and organize ongoing training for our CRAs. This ensures staff retention and that a high level of knowledge and competence in clinical research activities is maintained. We provide special training sessions specific to the CRA function. We have 7 modules available.

For SOP training, the ClinActis SOP Coordinator provides one hardcopy of the new/revised SOP to the appropriate ClinActis staff. The SOP should be relevant to the role and responsibilities of the staff. Each SOP will be accompanied with a SOP Distribution Cover Page (CORP 02A). The ClinActis SOP Coordinator sends the SOP and SOP Acknowledgement Receipt (CORP 028) to ClinActis staff.


All ClinActis staff will return original signed SOP Acknowledgement Receipt to SOP coordinator. If this is a revised SOP, the superseded version of the SOP must be returned to the SOP Coordinator. Appropriate training for non-complex SOPs can be self-reading of the SOP. Line manager/ department head(s) will forward SOP Self-reading Acknowledgement (CORP02C) to staff and request staff to return completed acknowledgement to line manager / department

head(s) after reading the SOP. Line manager/ department head(s) will instruct staff to complete reading the new/revised SOP before the Effective date of the SOP. After reading and understanding the SOP, ClinActis staff will complete the SOP Self-reading Acknowledgement and return to line manager / department head(s). All SOP Self Reading Acknowledgement will be forwarded to the Director, Clinical Research for filing. Formal training sessions for complex SOPs may be provided by the SOP author or a designee. Training should occur before the Effective date of the SOP. Line manager/department head(s) SOP author or designee will document the training on the SOP Training Log (CORP 020) and forward the Log to Director, Clinical Research for filing. SOPs are reviewed every two years and distributed to employees following the process described above. The SOPs CORP 01: CREATING, REVISING, APPROVING, REVIEWING AND DEVIATING FROM STANDARD OPERATING PROCEDURES and SOP CORP 02: DISTRIBUTION, NOTIFICATION AND CONTROL OF STANDARD OPERATING PROCEDURES cover these topics.

Q: Tell Us About the Importance of SOPs and How They Safeguard Clinical Trial Efficiency. (Continued)


SOP procedure described above is applied to all ClinActis employees whether centrally or regionally/home based. QUALITY CONTROL CHECKS TAKEN TO ENSURE PRODUCT OR SERVICE CONFORMITY: A Clinical Monitor must have at least two co-monitoring visits per year. Additional co-monitoring visits will be conducted if the assessment in one of the visits indicates the Clinical Monitor is not performing the responsibilities of the visit adequately.

Each study should have at least two co-monitoring visits. Considerations when determining the need to schedule the co-monitoring visit for a study include, but are not limited to, the following:

ü  Complexity of the study ü  Number of subjects enrolled ü  Duration of the study period ü  Issues identified in the monitoring reports and/or study status reports ü  Whether a QA audit of the study is planned ü  Feedback from the Project Manager regarding the Clinical Monitor’s performance on the study

For a CRA new in position, a co-monitoring visit should be conducted for each type of site visit: PSV, SIV, RMV and COV as soon as it is practical depending on the needs and stage of the study they are monitoring.



During the co-monitoring visit, the assessor team will assess the Clinical Monitor’s competencies with regard to ICH GCP compliance, adherence to ClinActis SOPs and study specific procedures. Check on patient eligibility, Informed Consent Form (ICF), Investigational Medicinal Product (IMP) accountability and patient’s safety will be done for randomly selected subjects. The assessor team will request that the Clinical Monitor provide the assessor a copy of any follow up documents after the visit, including the follow up letter and trip report. After the co-monitoring visit, the assessor will:

ü  Review the follow-up letter and trip report ü  Complete the co-monitoring Visit Report

In the report, the assessor will include a summary of the observations and document any identified issues which may include but are not limited to:

ü  Documentation or procedural deficiencies ü  Regulatory non-compliance ü  Time management skills ü  Non-adherence to ClinActis SOPs

The assessor will prepare a Corrective Action Plan (CAP) that includes the actions to be taken or recommendations to address the issues and/or improve operational performance and quality.



The assessor will forward a copy of the co-monitoring Visit Report and Quality Initiative Corrective Action Plan (CAP), if applicable, to the Clinical Monitor and Line Manager; along with the timeframe for the Clinical Monitor to respond to the co-monitoring Visit Report and the CAP. A copy of the co-monitoring Visit Report and CAP are forwarded to the QI Team if the members of the QI Team are not the Assessor. If any major issues are identified with the Clinical Monitor or the site, that may impact

patient safety, data integrity, study timelines and/or study budget, the assessor will escalate to the Line Manager and/or Project Manager for resolution in a timely manner. In summary, ClinActis has high quality SOPs which significantly safeguard the clinical trial efficiency especially during the startup, execution and study close out phase. The SOPs will also help to ensure consistent results and high quality in our work such as providing accurate and consistent data, complying with the protocol as per sponsor’s/clinical investigator’s specification, properly transferring patient information and data from patient case note into the CRF etc.



Q: What Advantages Do a Singapore Based CRO Offer Operationally to a Trial?

As a Singapore based CRO, ClinActis benefits from all advantages Singapore has to offer in the clinical research field. Singapore is a regional hub for healthcare services and biomedical science research. Singapore is strategically located at the heart of ASEAN, a market of over 500 million people. It has unlimited access to neighboring markets, with a total population of over 4 billion within a seven-hour flight radius.

Singapore offers great opportunities for innovation: Singapore is ranked as the #1 place in the world for ease of doing business in the World Bank’s ‘Doing Business 2011‘ report its world-class research institutions provide a strong science and innovation base to support biomedical discovery and development activities and international companies present in Singapore offer abundant opportunities to carry out R&D activities. Singapore has established a very solid regime for intellectual property protection, a sound regulatory framework, and it is a signatory to major Intellectual Properties treaties. Singapore has the third-best IPR protection regime in the world according to the World Economic Forum (WEF) ‘2010 Global Competitiveness Report‘, while Forbes magazine ranked Singapore #8 for property rights in its ‘2010 Best Countries for Business‘ list.


Singapore boasts of a formidable workforce that is best described as productive, hard-working, cosmopolitan, and English-speaking, able to understand international standards. Singapore has topped BERI’s (Business Environment Risk Intelligence) ‘Labor Force Evaluation Measure‘ for 30 consecutive years. Aon Consulting’s ‘2010 People Risk Index‘ ranks Singapore as #3 in the world for low risk of recruiting, employing, and relocating employees.

According to the World Economic Forum, Singapore has best labor-employer relations and the most productive workforce in the world. The availability of a skilled talent pool, with a density of 93 per 10,000, is on par with mature markets such as the US and Japan. In summary, Singapore presents a workforce second to none in Asia. As Singapore is striving to become a healthcare services hub, this has led to the increase of services that support biomedical sciences in Singapore and in the region. Singapore is the secretariat for the APEC Coordinating Centre for Good Clinical Practice; as such, Singapore has also been the focal point for the development of GCP in Asia, steering many initiatives such as the training of clinical research personnel and the creation of a favorable environment for multi-site clinical trials in the region.

Q: What Advantages Do a Singapore Based CRO Offer Operationally to a Trial? (Continued)


A range of factors are encouraging pharmaceutical companies to step up their presence in Asia. Together with the increasing importance of Asia as an end-customer market, growth in manufacturing and human capabilities are also providing compelling reasons for companies to build direct or outsourced capacity in the region.

The majority of pharmaceutical companies have established their regional headquarters as well as their regional clinical research units in Singapore, even though some of them have now established regional offices in China. In order to compete against the global giant CROs such as Quintiles, Covance, PPD, ICON, and PAREXEL, ClinActis has to create our unique business and project management model so as to conduct the clinical trials in a timely and cost-effective manner in Asia, with different regulatory frameworks taking into account the differences in culture in different countries.

Q: What Advantages Do a Singapore Based CRO Offer Operationally to a Trial? (Continued)


A Project Manager is a critical part of a study’s success. ClinActis assigns experienced project managers with proven expertise in clinical research. Your assigned project manager is responsible for the technical and administrative aspects of the study as defined by the client

Q: How Does a Project Manager Impact a Trial and are Processes Changed Based on It’s Specific Needs?

The role of your PM is to ensure compliance to the SOPs. As the PM is in the contact with the client, he may also identify specific needs for SOP adjustment or harmonization. In certain cases, we use either the sponsor’s SOPs or ClinActis SOPs. In other cases, we use a hybrid model with some SOPs from ClinActis and some SOPs from the sponsor. In this case, we will discuss harmonization and selection of the SOPs to be used for the project.


Q: How Can a ‘Local’ Clinical Monitor Benefit the Operational Efficiency of a Trial?

Due to the diversity of languages and cultures within the region, as well as to maximize cost and operational efficiency, ClinActis assigns or recruits locally-based CRAs in the individual country to cover the sites in their respective country. ClinActis CRAs have in-depth knowledge of the regulatory requirements and monitoring of clinical trials. All of our CRAs, both field-based and office-based, have experience in monitoring and have relevant clinical research experience.

In addition to their expertise in coordinating clinical studies, ClinActis CRAs are skilled in: ü  Development and maintenance of good working relationships with investigators and study staff ü  All aspects of site management to ensure quality of data generated by sites, resulting in

consistently low query levels and acceptable Quality Assurance reports ü  Pre-study, initiation, routine monitoring, and close-out of clinical sites as well as the maintenance

of study files ü  Establishment, updating, tracking, and maintenance of study-specific trial management tools/

systems ü  Preparation of accurate and timely trip reports


Q: How Can a ‘Local’ Clinical Monitor Benefit the Operational Efficiency of a Trial? (Continued)

ü  Tracking of clinical trial supplies ü  Review of CRFs and query resolution, including experience with

various EDC platforms such as RAVE and InForm. ü  SAE reporting process and follow-up of SAEs

All ClinActis’ CRAs have more than 3 years of monitoring experience.

The CRAs have a wide span of therapeutic knowledge. Many CRAs were formerly pharmacists, study coordinators, nurses, or medical doctors in some countries. A majority of our CRAs have previously worked for multinational pharmaceutical and CRO companies. This broad range of experience enables ClinActis to provide exceptional monitoring and site management capabilities to complement the project management expertise in ensuring the delivery of results and quality. ClinActis has been able to build a very comprehensive database of potential clinical research staff interested in joining ClinActis in all countries across the region. This is enabled by the vast experience, high credibility and extensive network built by ClinActis’ management team, and the very unique concept of our CRO which is highly attractive to clinical research professionals in the region.


Q: How Can a ‘Local’ Clinical Monitor Benefit the Operational Efficiency of a Trial? (Continued)

ClinActis is able to attract top talent in the region because it combines international quality standards with a deep understanding of the region and its local staff’s expectations. ClinActis requires our CRAs to demonstrate proficiency in site monitoring before allocated to a study and are mainly assigned to monitor sites in their home countries which provides the necessary understanding of local languages, regulations, customs and business practices.

Since ClinActis prepares our CRAs with study-specific training and who are familiar with local customs and regulatory requirements, this training and cultural knowledge helps to manage site workflow, reduce investigator burden, improve data quality and accelerate database lock.


Q: Can You Explain or Provide Your IRB/ERC & Regulatory Submission and Approval Process?

ClinActis has SOP and guidelines describing the process of IRB/ERCs and regulatory submission, including guides for completing the associated forms in compliance with local requirement. For the IRB/ERCs initial submission, ClinActis will assist site in preparation of master submission dossier, as well as to duplicate the Clinical trial package (CTP) to the number of copies that the site needs to perform the submission.

In our list of Master submission dossier may contain, but not limited to, documents like cover letter, submission Form (to be filled and signed by PI), compilation of essential documents (protocol with signature page, IB, ICF English and/or local language, Insurance, schedule of Study Assessments (if applicable), Draft/Finalized Clinical Study Agreement and budget, updated Safety Information (e.g. Safety Letters/CIOMS/MedWatch reports), CV and medical licenses of investigators. We will also help to prepare the check payment for IRB review fees. Moreover, ClinActis will also assist Sponsor to pre-plan all study activities that need to be accelerated during the startup phase. ClinActis would advise the sponsor to initiate the more time-consuming activities such as translating the ICF, reviewing of site budget, checking the IRB/EC meeting schedule and deadline etc, so as to shorten and accelerate the preparation submission in the countries.


Q: Can You Explain or Provide Your IRB/ERC & Regulatory Submission and Approval Process? (Continued)

Prior to IRB/ECs submission, ClinActis management group will perform a quality check using our standard IRB checklist to ensure the submission dossier is compliant with GCP, local IRB/EC regulations and other institution specific requirement before providing the green light to the CRA for the submission. Once the submission was performed, we will obtain a copy of the IRB/ECs submission letter and duplicate a copy of the CTP to be filed in the Site TMF as part of SOP process for TMF filing.

The site staff will be informed to file all the email correspondence between the site and IRB/ECs in their site TMF. In our guideline, we also clearly stated that CRA should not have direct contact with IRB/EC, hence, CRA may only assist PI in the submission. Upon receiving approval from IRB/EC, ClinActis will check that the approval letter contains particular information to be written in the documents, such as approval date, list of documents that have been submitted (with the correct version number and version date), IRB/EC membership list, statement indicating the IRB/EC operates according to ICH-GCP guidelines, and we will always ensure that the original IRB/EC approval letter is filed in the Investigator Site File as per our TMF SOP, and obtain a copy to be filed in the Local File and Central File accordingly.


Q: Can You Explain or Provide Your IRB/ERC & Regulatory Submission and Approval Process? (Continued)

For the regulatory submission and approval, process will be very similar to the dossier preparation to IRB/ECs, except we will need to provide more drug manufacturing information including the certificate of Analysis, GMP Certificate and other CMC data/ or reference to IMPD dossier. In our SOP, we describe how we assist sponsor in responding to queries/comments from Regulatory Authorities, and support the application of Import Licenses, label review and translation, as well as application for other study equipment that are needed for the trial.

Clinical regulatory experts serve as resources to create protocols that can be completed quickly and supported by sites. ClinActis provides support for Clinical Trial Application to Regulatory Authorities in Asia guiding the client through each step of the process. We’ll provide expert advice, attend planning meetings, prepare pre-meeting briefing packages, and facilitate communication with regulatory agencies.


Contact Us for More Information

Imen Jelassi, PharmD, MSc EU Director, Strategic Relations M: +33 6 28 11 13 71 E: [email protected]

Bill Van Nostrand Head of Business Development, North America M: +1 908-229-5220 E: [email protected]

Date post:	16-Apr-2017
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Q&A With Paul Lim: Director, Clinical Research

Health & Medicine